Details for New Drug Application (NDA): 022309
✉ Email this page to a colleague
The generic ingredient in ANDROGEL is testosterone. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 022309
Tradename: | ANDROGEL |
Applicant: | Besins Hlthcare |
Ingredient: | testosterone |
Patents: | 8 |
Pharmacology for NDA: 022309
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 022309
Suppliers and Packaging for NDA: 022309
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309 | NDA | AbbVie Inc. | 0051-8462 | 0051-8462-33 | 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP |
ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309 | NDA | AbbVie Inc. | 0051-8462 | 0051-8462-33 | 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP |
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 29, 2011 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 12, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 12, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 12, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE |
Expired US Patents for NDA 022309
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-002 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-002 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-002 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription