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 one supplier. 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 is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
The generic ingredient in ANDROGEL is testosterone. There is one drug master file entry for this compound. Sixteen 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 |
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 AUTHORIZED GENERIC | Prasco Laboratories | 66993-951 | 66993-951-88 | 1 BOTTLE, PUMP in 1 CARTON (66993-951-88) / 88 g in 1 BOTTLE, PUMP |
| ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-951 | 66993-951-88 | 1 BOTTLE, PUMP in 1 CARTON (66993-951-88) / 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: | 8,466,136 | Patent Expiration: | Oct 12, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,466,137 | 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: | 8,466,138 | 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 | ||||||||
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