Details for New Drug Application (NDA): 208204
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NDA 208204 describes BETAMETHASONE VALERATE, which is a drug marketed by Novast Labs, Padagis Israel, Taro, Xiromed, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Anima, Teva Pharms, and Actavis Mid Atlantic, and is included in nineteen NDAs. It is available from ten 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.
Summary for 208204
| Tradename: | BETAMETHASONE VALERATE |
| Applicant: | Taro |
| Ingredient: | betamethasone valerate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208204
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208204
Suppliers and Packaging for NDA: 208204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 208204 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4188 | 51672-4188-3 | 1 CAN in 1 CARTON (51672-4188-3) / 50 g in 1 CAN |
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 208204 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4188 | 51672-4188-7 | 1 CAN in 1 CARTON (51672-4188-7) / 100 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.12% | ||||
| Approval Date: | May 24, 2017 | TE: | AB | RLD: | No | ||||
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