Details for New Drug Application (NDA): 204570
✉ 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 204570
Tradename: | TESTOSTERONE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | testosterone |
Patents: | 0 |
Pharmacology for NDA: 204570
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 204570
Suppliers and Packaging for NDA: 204570
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 204570 | ANDA | Actavis Pharma, Inc. | 0591-2924 | 0591-2924-18 | 1 BOTTLE, PUMP in 1 CARTON (0591-2924-18) / 88 g in 1 BOTTLE, PUMP |
TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 204570 | ANDA | Actavis Pharma, Inc. | 0591-2925 | 0591-2925-30 | 30 PACKET in 1 CARTON (0591-2925-30) / 1.25 g in 1 PACKET (0591-2925-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 1.62% (20.25MG/1.25GM ACTUATION) | ||||
Approval Date: | Apr 10, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 1.62% (20.25MG/1.25GM PACKET) | ||||
Approval Date: | Jul 17, 2020 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 1.62% (40.5MG/2.5GM PACKET) | ||||
Approval Date: | Jul 17, 2020 | TE: | AB2 | RLD: | No |
Complete Access Available with Subscription