Details for New Drug Application (NDA): 076744
✉ Email this page to a colleague
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 076744
Tradename: | TESTOSTERONE |
Applicant: | Strides Pharma |
Ingredient: | testosterone |
Patents: | 0 |
Pharmacology for NDA: 076744
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 076744
Suppliers and Packaging for NDA: 076744
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 076744 | ANDA | Par Pharmaceutical, Inc. | 49884-418 | 49884-418-72 | 30 PACKET in 1 CARTON (49884-418-72) / 2.5 g in 1 PACKET (49884-418-48) |
TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 076744 | ANDA | Par Pharmaceutical, Inc. | 49884-510 | 49884-510-72 | 30 PACKET in 1 CARTON (49884-510-72) / 5 g in 1 PACKET (49884-510-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 25MG/2.5GM PACKET | ||||
Approval Date: | May 23, 2007 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET | ||||
Approval Date: | May 23, 2007 | TE: | AB1 | RLD: | No |
Complete Access Available with Subscription