Details for New Drug Application (NDA): 076737
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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 076737
Tradename: | TESTOSTERONE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | testosterone |
Patents: | 0 |
Pharmacology for NDA: 076737
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 076737
Suppliers and Packaging for NDA: 076737
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 076737 | ANDA | Actavis Pharma, Inc. | 0591-2921 | 0591-2921-02 | 2 BOTTLE, PUMP in 1 CARTON (0591-2921-02) / 75 g in 1 BOTTLE, PUMP (0591-2921-18) |
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 076737 | ANDA | Actavis Pharma, Inc. | 0591-3216 | 0591-3216-30 | 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 25MG/2.5GM PACKET | ||||
Approval Date: | Jan 27, 2006 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
Approval Date: | Jan 27, 2006 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 12.5MG/1.25GM ACTUATION | ||||
Approval Date: | Mar 9, 2015 | TE: | AB1 | RLD: | No |
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