Details for New Drug Application (NDA): 209836
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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 209836
Tradename: | TESTOSTERONE |
Applicant: | Twi Pharms |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209836
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209836
Suppliers and Packaging for NDA: 209836
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 209836 | ANDA | TWi Pharmaceuticals, Inc. | 24979-130 | 24979-130-26 | 1 BOTTLE, PUMP in 1 CARTON (24979-130-26) / 110 mL in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, METERED;TRANSDERMAL | Strength | 30MG/1.5ML ACTUATION | ||||
Approval Date: | Sep 3, 2021 | TE: | AT | RLD: | No |
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