Details for New Drug Application (NDA): 020489
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NDA 020489 describes ANDRODERM, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. Additional details are available on the ANDRODERM profile page.
The generic ingredient in ANDRODERM is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
The generic ingredient in ANDRODERM is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 020489
| Tradename: | ANDRODERM |
| Applicant: | Allergan |
| Ingredient: | testosterone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020489
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020489
Suppliers and Packaging for NDA: 020489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489 | NDA | Allergan, Inc. | 0023-5990 | 0023-5990-60 | 60 POUCH in 1 CARTON (0023-5990-60) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH |
| ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489 | NDA | Allergan, Inc. | 0023-5992 | 0023-5992-30 | 30 POUCH in 1 CARTON (0023-5992-30) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 2.5MG/24HR | ||||
| Approval Date: | Sep 29, 1995 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 5MG/24HR | ||||
| Approval Date: | May 2, 1997 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 2MG/24HR | ||||
| Approval Date: | Oct 20, 2011 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020489
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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