Details for New Drug Application (NDA): 091073
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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 091073
Tradename: | TESTOSTERONE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091073
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 091073
Suppliers and Packaging for NDA: 091073
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 091073 | ANDA | Actavis Pharma, Inc. | 0591-3524 | 0591-3524-30 | 30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
Approval Date: | Sep 18, 2017 | TE: | AB2 | RLD: | No |
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