Details for New Drug Application (NDA): 211882
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The generic ingredient in ARAZLO 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 211882
Tradename: | ARAZLO |
Applicant: | Bausch |
Ingredient: | tazarotene |
Patents: | 2 |
Suppliers and Packaging for NDA: 211882
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARAZLO | tazarotene | LOTION;TOPICAL | 211882 | NDA | Bausch Health US, LLC | 0187-2098 | 0187-2098-10 | 10 TUBE in 1 CARTON (0187-2098-10) / 3 g in 1 TUBE (0187-2098-03) |
ARAZLO | tazarotene | LOTION;TOPICAL | 211882 | NDA | Bausch Health US, LLC | 0187-2098 | 0187-2098-45 | 1 TUBE in 1 CARTON (0187-2098-45) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.045% | ||||
Approval Date: | Dec 18, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 11, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 6, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 211882
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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