Details for New Drug Application (NDA): 210835
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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 210835
Tradename: | TESTOSTERONE |
Applicant: | Xiromed |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210835
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210835
Suppliers and Packaging for NDA: 210835
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 210835 | ANDA | Bryant Ranch Prepack | 63629-2352 | 63629-2352-1 | 1 BOTTLE, PUMP in 1 CARTON (63629-2352-1) / 88 g in 1 BOTTLE, PUMP |
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 210835 | ANDA | Xiromed, LLC | 70700-112 | 70700-112-21 | 1 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 88 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 1.62% (20.25MG/1.25GM ACTUATION) | ||||
Approval Date: | Apr 16, 2020 | TE: | AB | RLD: | No |
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