Details for New Drug Application (NDA): 212984
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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 212984
Tradename: | TESTOSTERONE |
Applicant: | Encube |
Ingredient: | testosterone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212984
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212984
Suppliers and Packaging for NDA: 212984
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 212984 | ANDA | Encube Ethicals Private Limited | 21922-019 | 21922-019-02 | 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET |
TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 212984 | ANDA | Encube Ethicals Private Limited | 21922-019 | 21922-019-47 | 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
Approval Date: | Nov 9, 2021 | TE: | AB1 | RLD: | No |
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