Details for New Drug Application (NDA): 021463
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The generic ingredient in FORTESTA is testosterone. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 021463
Tradename: | FORTESTA |
Applicant: | Endo Pharms |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021463
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021463
Suppliers and Packaging for NDA: 021463
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463 | NDA | Endo Pharmaceuticals Inc. | 63481-183 | 63481-183-16 | 1 CANISTER in 1 CARTON (63481-183-16) / 60 g in 1 CANISTER |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 10MG/0.5GM ACTUATION | ||||
Approval Date: | Dec 29, 2010 | TE: | RLD: | Yes |
Expired US Patents for NDA 021463
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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