Details for New Drug Application (NDA): 215832
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NDA 215832 describes BETAMETHASONE VALERATE, which is a drug marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Sun Pharma Canada, Senores Pharms, Teva Pharms, and Actavis Mid Atlantic, and is included in twenty NDAs. It is available from nine suppliers. Additional details are available on the BETAMETHASONE VALERATE profile page.
The generic ingredient in BETAMETHASONE VALERATE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.
The generic ingredient in BETAMETHASONE VALERATE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.
Summary for 215832
| Tradename: | BETAMETHASONE VALERATE |
| Applicant: | Alembic |
| Ingredient: | betamethasone valerate |
| Patents: | 0 |
Pharmacology for NDA: 215832
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215832
Suppliers and Packaging for NDA: 215832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 215832 | ANDA | Alembic Pharmaceuticals Limited | 46708-708 | 46708-708-31 | 1 CAN in 1 CARTON (46708-708-31) / 100 g in 1 CAN |
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 215832 | ANDA | Alembic Pharmaceuticals Limited | 46708-708 | 46708-708-50 | 1 CAN in 1 CARTON (46708-708-50) / 50 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.12% | ||||
| Approval Date: | Aug 22, 2024 | TE: | AB | RLD: | No | ||||
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