Details for New Drug Application (NDA): 204255
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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 204255
Tradename: | TESTOSTERONE |
Applicant: | Padagis Israel |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204255
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 204255
Suppliers and Packaging for NDA: 204255
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 204255 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-610 | 45802-610-01 | 1 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP |
TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 204255 | ANDA | Bryant Ranch Prepack | 63629-9310 | 63629-9310-1 | 1 BOTTLE, PUMP in 1 CARTON (63629-9310-1) / 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: | Feb 28, 2017 | TE: | AT | RLD: | No |
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