Details for New Drug Application (NDA): 204637
✉ Email this page to a colleague
NDA 204637 describes AZELAIC ACID, which is a drug marketed by Teva Pharms Usa, Actavis Labs Ut Inc, Encube, Glenmark Speclt, and Taro, and is included in five NDAs. It is available from five suppliers. Additional details are available on the AZELAIC ACID profile page.
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.
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 204637
| Tradename: | AZELAIC ACID |
| Applicant: | Glenmark Speclt |
| Ingredient: | azelaic acid |
| Patents: | 0 |
Pharmacology for NDA: 204637
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 204637
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZELAIC ACID | azelaic acid | GEL;TOPICAL | 204637 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-626 | 68462-626-52 | 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 15% | ||||
| Approval Date: | Nov 19, 2018 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
