پرومتازین هیدروکلراید (Promethazine Hydrochloride)
۱۳۷ محصول ثبت‌شده متوقف‌شده ANDANDA
خلاصهٔ ثبت FDA
- فرم‌های دارویی
- TABLET;ORAL · INJECTABLE;INJECTION · SUPPOSITORY;RECTAL
- دوزهای ثبت‌شده
- 25MG · 12.5MG · 50MG · 25MG/ML
- شرکت‌های دارنده
- WATSON LABS · ABLE · SANDOZ · ABBOTT
- پروندهٔ رسمی
- 007935
محصولات ثبت‌شده (نمایش ۸۰ از ۱۳۷)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| PHENERGAN | TABLET;ORAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | DELCOR ASSET CORP | NDA | متوقف‌شده | 007935 |
| PHENERGAN | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | DELCOR ASSET CORP | NDA | متوقف‌شده | 007935 |
| PHENERGAN | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | DELCOR ASSET CORP | NDA | متوقف‌شده | 007935 |
| PROMETHAZINE HYDROCHLORIDE PLAIN | SYRUP;ORAL | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ANI PHARMS | NDA | متوقف‌شده | 008381 |
| PROMETHAZINE HYDROCHLORIDE PLAIN | SYRUP;ORAL | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ANI PHARMS | NDA | متوقف‌شده | 008381 |
| PHENERGAN | INJECTABLE;INJECTION | 25MG/ML | WYETH AYERST | NDA | متوقف‌شده | 008857 |
| PHENERGAN | INJECTABLE;INJECTION | 50MG/ML | WYETH AYERST | NDA | متوقف‌شده | 008857 |
| PHENERGAN | SUPPOSITORY;RECTAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PHARMOBEDIENT | NDA | متوقف‌شده | 010926 |
| PHENERGAN | SUPPOSITORY;RECTAL | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PHARMOBEDIENT | NDA | متوقف‌شده | 010926 |
| PHENERGAN | SUPPOSITORY;RECTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PHARMOBEDIENT | NDA | متوقف‌شده | 011689 |
| PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | CHARTWELL RX | ANDA | نسخه‌ای | 040026 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | HOSPIRA | ANDA | متوقف‌شده | 040372 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | HOSPIRA | ANDA | متوقف‌شده | 040372 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | COSETTE PHARMS NC | ANDA | نسخه‌ای | 040428 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | COSETTE PHARMS NC | ANDA | نسخه‌ای | 040428 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 50MG | ABLE | ANDA | متوقف‌شده | 040449 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TEVA PHARMS USA | ANDA | متوقف‌شده | 040454 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TEVA PHARMS USA | ANDA | متوقف‌شده | 040454 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | MYLAN INSTITUTIONAL | ANDA | متوقف‌شده | 040471 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | WATSON LABS INC | ANDA | متوقف‌شده | 040479 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | WATSON LABS INC | ANDA | متوقف‌شده | 040479 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | PADAGIS ISRAEL | ANDA | نسخه‌ای | 040500 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | PADAGIS ISRAEL | ANDA | نسخه‌ای | 040500 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | ABLE | ANDA | متوقف‌شده | 040504 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | ABLE | ANDA | متوقف‌شده | 040504 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | AM REGENT | ANDA | متوقف‌شده | 040515 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | BEDFORD LABS | ANDA | متوقف‌شده | 040524 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | BEDFORD LABS | ANDA | متوقف‌شده | 040524 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | ABLE | ANDA | متوقف‌شده | 040558 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | ABLE | ANDA | متوقف‌شده | 040558 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | ABLE | ANDA | متوقف‌شده | 040558 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | SANDOZ | ANDA | متوقف‌شده | 040593 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | SANDOZ | ANDA | متوقف‌شده | 040593 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | ZYDUS PHARMS USA | ANDA | نسخه‌ای | 040596 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | ZYDUS PHARMS USA | ANDA | نسخه‌ای | 040596 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | ZYDUS PHARMS USA | ANDA | نسخه‌ای | 040596 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | SUN PHARMA CANADA | ANDA | متوقف‌شده | 040603 |
| PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | SUN PHARMA CANADA | ANDA | متوقف‌شده | 040603 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | PRINSTON | ANDA | نسخه‌ای | 040622 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | PRINSTON | ANDA | نسخه‌ای | 040622 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | PRINSTON | ANDA | نسخه‌ای | 040622 |
| PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | PHARM ASSOC | ANDA | نسخه‌ای | 040643 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | QUAGEN | ANDA | نسخه‌ای | 040673 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | QUAGEN | ANDA | نسخه‌ای | 040673 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | QUAGEN | ANDA | نسخه‌ای | 040673 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | KVK TECH | ANDA | نسخه‌ای | 040712 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | KVK TECH | ANDA | نسخه‌ای | 040712 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | KVK TECH | ANDA | نسخه‌ای | 040712 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | KVK TECH | ANDA | نسخه‌ای | 040713 |
| PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | SUN PHARMA CANADA | ANDA | متوقف‌شده | 040718 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | XGEN PHARMS | ANDA | نسخه‌ای | 040737 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | XGEN PHARMS | ANDA | نسخه‌ای | 040737 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | WOCKHARDT BIO AG | ANDA | متوقف‌شده | 040785 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | WOCKHARDT BIO AG | ANDA | متوقف‌شده | 040785 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | IMPAX LABS | ANDA | متوقف‌شده | 040791 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | IMPAX LABS | ANDA | متوقف‌شده | 040791 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | IMPAX LABS | ANDA | متوقف‌شده | 040791 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | SUN PHARM INDS INC | ANDA | متوقف‌شده | 040863 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | SUN PHARM INDS INC | ANDA | متوقف‌شده | 040863 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | SUN PHARM INDS INC | ANDA | متوقف‌شده | 040863 |
| PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | AMNEAL PHARMS | ANDA | متوقف‌شده | 040882 |
| PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | STRIDES PHARMA | ANDA | نسخه‌ای | 040891 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | WATSON LABS | ANDA | متوقف‌شده | 080629 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | CHARTWELL MOLECULAR | ANDA | متوقف‌شده | 080949 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | CHARTWELL MOLECULAR | ANDA | متوقف‌شده | 080949 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | CHARTWELL MOLECULAR | ANDA | متوقف‌شده | 080949 |
| REMSED | TABLET;ORAL | 50MG | BRISTOL MYERS SQUIBB | ANDA | متوقف‌شده | 083176 |
| REMSED | TABLET;ORAL | 25MG | BRISTOL MYERS SQUIBB | ANDA | متوقف‌شده | 083176 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | WATSON LABS | ANDA | متوقف‌شده | 083204 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | PVT FORM | ANDA | متوقف‌شده | 083214 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | HIKMA | ANDA | نسخه‌ای | 083312 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | HIKMA | ANDA | نسخه‌ای | 083312 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | WATSON LABS | ANDA | متوقف‌شده | 083401 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | WATSON LABS | ANDA | متوقف‌شده | 083403 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | WATSON LABS | ANDA | نسخه‌ای | 083426 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | WATSON LABS | ANDA | متوقف‌شده | 083532 |
| PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | WATSON LABS | ANDA | متوقف‌شده | 083532 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | IVAX SUB TEVA PHARMS | ANDA | متوقف‌شده | 083603 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | IVAX SUB TEVA PHARMS | ANDA | متوقف‌شده | 083604 |
| PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | IVAX SUB TEVA PHARMS | ANDA | متوقف‌شده | 083613 |
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