فنتانیل سیترات (Fentanyl Citrate)
۷۲ محصول ثبت‌شده متوقف‌شده NDAANDA
خلاصهٔ ثبت FDA
- فرم‌های دارویی
- TROCHE/LOZENGE;TRANSMUCOSAL · TABLET;BUCCAL, SUBLINGUAL · TABLET;SUBLINGUAL
- شرکت‌های دارنده
- CEPHALON · SENTYNL THERAPS INC · WATSON LABS · PAR PHARM
- پروندهٔ رسمی
- 020747
محصولات ثبت‌شده (۷۲ مورد)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| SUBLIMAZE PRESERVATIVE FREE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | RISING | NDA | نسخه‌ای | 016619 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | HIKMA | NDA | نسخه‌ای | 019101 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.025MG BASE/0.5ML | HIKMA | NDA | متوقف‌شده | 019101 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | HOSPIRA | NDA | نسخه‌ای | 019115 |
| FENTANYL | TROCHE/LOZENGE;ORAL | EQ 0.2MG BASE | CEPHALON | NDA | متوقف‌شده | 020195 |
| FENTANYL | TROCHE/LOZENGE;ORAL | EQ 0.3MG BASE | CEPHALON | NDA | متوقف‌شده | 020195 |
| FENTANYL | TROCHE/LOZENGE;ORAL | EQ 0.4MG BASE | CEPHALON | NDA | متوقف‌شده | 020195 |
| FENTANYL | TROCHE/LOZENGE;ORAL | EQ 0.1MG BASE | CEPHALON | NDA | متوقف‌شده | 020195 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 020747 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CEPHALON | NDA | متوقف‌شده | 021947 |
| ONSOLIS | FILM;BUCCAL | EQ 0.2MG BASE | ADALVO | NDA | متوقف‌شده | 022266 |
| ONSOLIS | FILM;BUCCAL | EQ 0.4MG BASE | ADALVO | NDA | متوقف‌شده | 022266 |
| ONSOLIS | FILM;BUCCAL | EQ 0.6MG BASE | ADALVO | NDA | متوقف‌شده | 022266 |
| ONSOLIS | FILM;BUCCAL | EQ 0.8MG BASE | ADALVO | NDA | متوقف‌شده | 022266 |
| ONSOLIS | FILM;BUCCAL | EQ 1.2MG BASE | ADALVO | NDA | متوقف‌شده | 022266 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| ABSTRAL | TABLET;SUBLINGUAL | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SENTYNL THERAPS INC | NDA | متوقف‌شده | 022510 |
| LAZANDA | SPRAY, METERED;NASAL | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BTCP PHARMA | NDA | متوقف‌شده | 022569 |
| LAZANDA | SPRAY, METERED;NASAL | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BTCP PHARMA | NDA | متوقف‌شده | 022569 |
| LAZANDA | SPRAY, METERED;NASAL | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BTCP PHARMA | NDA | متوقف‌شده | 022569 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | ABBOTT | ANDA | متوقف‌شده | 070636 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | ABBOTT | ANDA | متوقف‌شده | 070637 |
| FENTANYL CITRATE PRESERVATIVE FREE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | HOSPIRA | ANDA | متوقف‌شده | 072786 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | WATSON LABS | ANDA | متوقف‌شده | 073488 |
| FENTANYL CITRATE PRESERVATIVE FREE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | DR REDDYS | ANDA | متوقف‌شده | 074917 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.2MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.4MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.6MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.8MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.2MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.6MG BASE | PAR PHARM | ANDA | متوقف‌شده | 077312 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.2MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.4MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.6MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.8MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.2MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.6MG BASE | SPECGX LLC | ANDA | متوقف‌شده | 078907 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.1MG BASE | WATSON LABS | ANDA | متوقف‌شده | 079075 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.2MG BASE | WATSON LABS | ANDA | متوقف‌شده | 079075 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE | WATSON LABS | ANDA | متوقف‌شده | 079075 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE | WATSON LABS | ANDA | متوقف‌شده | 079075 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE | WATSON LABS | ANDA | متوقف‌شده | 079075 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.1MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.2MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.3MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE | DR REDDYS LABS SA | ANDA | متوقف‌شده | 206329 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.1MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.2MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.3MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.4MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.6MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.8MG BASE | ACTAVIS LABS FL INC | ANDA | متوقف‌شده | 207338 |
| FENTANYL CITRATE PRESERVATIVE FREE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | FRESENIUS KABI USA | ANDA | نسخه‌ای | 210762 |
| FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | FRESENIUS KABI USA | ANDA | نسخه‌ای | 212086 |
| FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | EXELA PHARMA | NDA | متوقف‌شده | 215870 |
| FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | EXELA PHARMA | NDA | متوقف‌شده | 215870 |
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داده‌ها از فایل‌های رسمی Drugs@FDA data files (Products، Applications و MarketingStatus) گرفته شده‌اند. هر ردیف جدول یک محصول ثبت‌شده با همان مادهٔ مؤثره است؛ شمارهٔ پرونده به صفحهٔ رسمی FDA لینک دارد. وضعیت «متوقف‌شده» یعنی محصول دیگر توزیع نمی‌شود.
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