Details for New Drug Application (NDA): 021015
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NDA 021015 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 021015
| Tradename: | ANDROGEL |
| Applicant: | Besins Hlthcare |
| Ingredient: | testosterone |
| Patents: | 0 |
Pharmacology for NDA: 021015
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021015
Suppliers and Packaging for NDA: 021015
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015 | NDA | ASCEND Therapeutics U.S., LLC | 17139-501 | 17139-501-02 | 2 BOTTLE, PUMP in 1 CARTON (17139-501-02) / 75 g in 1 BOTTLE, PUMP |
| ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015 | NDA | ASCEND Therapeutics U.S., LLC | 17139-525 | 17139-525-30 | 30 PACKET in 1 CARTON (17139-525-30) / 2.5 g in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 28, 2000 | TE: | AB1 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TRANSDERMAL | Strength | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 28, 2000 | TE: | AB1 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TRANSDERMAL | Strength | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 26, 2003 | TE: | AB1 | RLD: | Yes | ||||
Expired US Patents for NDA 021015
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-001 | Feb 28, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015-003 | Sep 26, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-001 | Feb 28, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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