Details for New Drug Application (NDA): 210549
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The generic ingredient in AZELAIC ACID 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 210549
Tradename: | AZELAIC ACID |
Applicant: | Taro |
Ingredient: | azelaic acid |
Patents: | 0 |
Pharmacology for NDA: 210549
Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 210549
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELAIC ACID | azelaic acid | GEL;TOPICAL | 210549 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1389 | 51672-1389-3 | 1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 15% | ||||
Approval Date: | Aug 23, 2019 | TE: | AB | RLD: | No |
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