Details for New Drug Application (NDA): 202428
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NDA 202428 describes FABIOR, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the FABIOR profile page.
The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
Summary for 202428
| Tradename: | FABIOR |
| Applicant: | Mayne Pharma |
| Ingredient: | tazarotene |
| Patents: | 3 |
Suppliers and Packaging for NDA: 202428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FABIOR | tazarotene | AEROSOL, FOAM;TOPICAL | 202428 | NDA | Mayne Pharma | 51862-295 | 51862-295-10 | 1 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CAN |
| FABIOR | tazarotene | AEROSOL, FOAM;TOPICAL | 202428 | NDA AUTHORIZED GENERIC | Mayne Pharma Inc. | 68308-685 | 68308-685-50 | 1 CAN in 1 CARTON (68308-685-50) / 50 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | May 11, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 24, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 24, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 24, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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