تستوسترون (Testosterone)
۶۰ محصول ثبتشده نسخهای ANDANDA
خلاصهٔ ثبت FDA
- فرمهای دارویی
- GEL;TRANSDERMAL · GEL, METERED;TRANSDERMAL · SOLUTION, METERED;TRANSDERMAL
- دوزهای ثبتشده
- 30MG/1.5ML ACTUATION · 50MG/5GM PACKET · 1.62% (20.25MG/1.25GM ACTUATION) · 25MG/2.5GM PACKET
- شرکتهای دارنده
- ACTAVIS LABS UT INC · BESINS HLTHCARE · ENCUBE · ABBVIE
- پروندهٔ رسمی
- 020489
محصولات ثبتشده (۶۰ مورد)
| نام محصول | فرم | دوز | شرکت | نوع | وضعیت | پرونده |
|---|---|---|---|---|---|---|
| TESTODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 4MG/24HR | ALZA | NDA | متوقفشده | 019762 |
| TESTODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 6MG/24HR | ALZA | NDA | متوقفشده | 019762 |
| ANDRODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 2.5MG/24HR | ABBVIE | NDA | متوقفشده | 020489 |
| ANDRODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MG/24HR | ABBVIE | NDA | متوقفشده | 020489 |
| ANDRODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | NDA | متوقفشده | 020489 |
| ANDRODERM | FILM, EXTENDED RELEASE;TRANSDERMAL | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | NDA | متوقفشده | 020489 |
| TESTODERM TTS | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MG/24HR | ALZA | NDA | متوقفشده | 020791 |
| ANDROGEL | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | BESINS HLTHCARE | NDA | نسخهای | 021015 |
| ANDROGEL | GEL;TRANSDERMAL | 50MG/5GM PACKET | BESINS HLTHCARE | NDA | نسخهای | 021015 |
| ANDROGEL | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | BESINS HLTHCARE | NDA | نسخهای | 021015 |
| TESTIM | GEL;TRANSDERMAL | 50MG/5GM PACKET | ENDO OPERATIONS | NDA | نسخهای | 021454 |
| FORTESTA | GEL, METERED;TRANSDERMAL | 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ENDO OPERATIONS | NDA | متوقفشده | 021463 |
| STRIANT | TABLET, EXTENDED RELEASE;BUCCAL | 30MG | AUXILIUM PHARMS LLC | NDA | متوقفشده | 021543 |
| ANDROGEL | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | BESINS HLTHCARE | NDA | نسخهای | 022309 |
| ANDROGEL | GEL;TRANSDERMAL | 1.62% (20.25MG/1.25GM PACKET) | BESINS HLTHCARE | NDA | نسخهای | 022309 |
| ANDROGEL | GEL;TRANSDERMAL | 1.62% (40.5MG/2.5GM PACKET) | BESINS HLTHCARE | NDA | نسخهای | 022309 |
| AXIRON | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ELI LILLY AND CO | NDA | متوقفشده | 022504 |
| TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | ACTAVIS LABS UT INC | ANDA | نسخهای | 076737 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | ACTAVIS LABS UT INC | ANDA | نسخهای | 076737 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | ACTAVIS LABS UT INC | ANDA | نسخهای | 076737 |
| TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | STRIDES PHARMA INTL | ANDA | نسخهای | 076744 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | STRIDES PHARMA INTL | ANDA | نسخهای | 076744 |
| TESTOPEL | PELLET;IMPLANTATION | 75MG | ENDO OPERATIONS | ANDA | نسخهای | 080911 |
| TESTOSTERONE | INJECTABLE;INJECTION | 100MG/ML | DR REDDYS | ANDA | متوقفشده | 086417 |
| TESTOSTERONE | INJECTABLE;INJECTION | 50MG/ML | WATSON LABS | ANDA | متوقفشده | 086419 |
| TESTOSTERONE | INJECTABLE;INJECTION | 25MG/ML | WATSON LABS | ANDA | متوقفشده | 086420 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | ACTAVIS LABS UT INC | ANDA | نسخهای | 091073 |
| TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | ANI PHARMS | NDA | متوقفشده | 202763 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | ANI PHARMS | NDA | متوقفشده | 202763 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | PERRIGO ISRAEL | NDA | متوقفشده | 203098 |
| TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | PERRIGO ISRAEL | NDA | متوقفشده | 203098 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | PERRIGO ISRAEL | NDA | متوقفشده | 203098 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | PADAGIS ISRAEL | ANDA | نسخهای | 204255 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | PADAGIS ISRAEL | ANDA | نسخهای | 204268 |
| VOGELXO | GEL;TRANSDERMAL | 50MG/5GM PACKET | UPSHER SMITH LABS | NDA | نسخهای | 204399 |
| VOGELXO | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | UPSHER SMITH LABS | NDA | نسخهای | 204399 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | ACTAVIS LABS UT INC | ANDA | نسخهای | 204570 |
| TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (20.25MG/1.25GM PACKET) | ACTAVIS LABS UT INC | ANDA | نسخهای | 204570 |
| TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (40.5MG/2.5GM PACKET) | ACTAVIS LABS UT INC | ANDA | نسخهای | 204570 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 10MG/0.5GM ACTUATION | ACTAVIS LABS UT INC | ANDA | نسخهای | 204571 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | ACTAVIS LABS UT INC | ANDA | نسخهای | 205328 |
| NATESTO | GEL, METERED;NASAL | 5.5MG/0.122GM ACTUATION | ACERUS | NDA | نسخهای | 205488 |
| TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (20.25MG/1.25GM PACKET) | PADAGIS ISRAEL | ANDA | نسخهای | 205781 |
| TESTOSTERONE | GEL;TRANSDERMAL | 1.62% (40.5MG/2.5GM PACKET) | PADAGIS ISRAEL | ANDA | نسخهای | 205781 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | SANDOZ INC | ANDA | تأیید مشروط | 207337 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | AMNEAL | ANDA | نسخهای | 207373 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | LUPIN | ANDA | نسخهای | 208061 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | LUPIN | ANDA | نسخهای | 208560 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | ENCUBE | ANDA | نسخهای | 208620 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | APOTEX | ANDA | متوقفشده | 209181 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | TWI PHARMS | ANDA | متوقفشده | 209390 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | CIPLA | ANDA | نسخهای | 209533 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | TWI PHARMS | ANDA | متوقفشده | 209836 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | XIROMED | ANDA | نسخهای | 210835 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | ENCUBE | ANDA | نسخهای | 212301 |
| TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | ALEMBIC | ANDA | متوقفشده | 212882 |
| TESTOSTERONE | GEL;TRANSDERMAL | 50MG/5GM PACKET | ENCUBE | ANDA | نسخهای | 212984 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 12.5MG/1.25GM ACTUATION | ENCUBE | ANDA | نسخهای | 212984 |
| TESTOSTERONE | GEL;TRANSDERMAL | 25MG/2.5GM PACKET | ENCUBE | ANDA | نسخهای | 212984 |
| TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | ALEMBIC | ANDA | متوقفشده | 213922 |
این پرونده از کجا میآید؟
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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