Details for New Drug Application (NDA): 208061
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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 208061
Tradename: | TESTOSTERONE |
Applicant: | Lupin Ltd |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208061
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208061
Suppliers and Packaging for NDA: 208061
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 208061 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-943 | 68180-943-11 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68180-943-11) / 90 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, METERED;TRANSDERMAL | Strength | 30MG/1.5ML ACTUATION | ||||
Approval Date: | Oct 23, 2017 | TE: | AT | RLD: | No |
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