Details for New Drug Application (NDA): 204571
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The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for 204571
Tradename: | TESTOSTERONE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | testosterone |
Patents: | 0 |
Pharmacology for NDA: 204571
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 204571
Suppliers and Packaging for NDA: 204571
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 204571 | ANDA | Actavis Pharma, Inc. | 0591-2363 | 0591-2363-60 | 1 CANISTER in 1 CARTON (0591-2363-60) / 60 g in 1 CANISTER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 10MG/0.5GM ACTUATION | ||||
Approval Date: | Aug 5, 2015 | TE: | RLD: | No |
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