Details for New Drug Application (NDA): 020428
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The generic ingredient in AZELEX is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 020428
Tradename: | AZELEX |
Applicant: | Almirall |
Ingredient: | azelaic acid |
Patents: | 0 |
Pharmacology for NDA: 020428
Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 020428
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELEX | azelaic acid | CREAM;TOPICAL | 020428 | NDA | Almirall, LLC | 16110-869 | 16110-869-30 | 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE |
AZELEX | azelaic acid | CREAM;TOPICAL | 020428 | NDA | Almirall, LLC | 16110-869 | 16110-869-50 | 1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 20% | ||||
Approval Date: | Sep 13, 1995 | TE: | RLD: | Yes |
Expired US Patents for NDA 020428
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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