Details for New Drug Application (NDA): 208724
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NDA 208724 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 208724
| Tradename: | AZELAIC ACID |
| Applicant: | Encube |
| Ingredient: | azelaic acid |
| Patents: | 0 |
Pharmacology for NDA: 208724
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 208724
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208724 | ANDA | Encube Ethicals Private Limited | 21922-038 | 21922-038-14 | 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE |
| AZELAIC ACID | azelaic acid | GEL;TOPICAL | 208724 | ANDA | Bryant Ranch Prepack | 72162-2297 | 72162-2297-2 | 1 TUBE in 1 CARTON (72162-2297-2) / 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 | ||||
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