Details for New Drug Application (NDA): 022309
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NDA 022309 describes ANDROGEL, which is a drug marketed by Besins Hlthcare and is included in two NDAs. It is available from two suppliers. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ANDROGEL profile page.
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.
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 | 022309-003 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | 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 | 022309-002 | 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 |
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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