Details for New Drug Application (NDA): 078337
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NDA 078337 describes BETAMETHASONE VALERATE, which is a drug marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Sciegen Pharms Inc, Teva Pharms, and Actavis Mid Atlantic, and is included in twenty 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. 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 078337
| Tradename: | BETAMETHASONE VALERATE |
| Applicant: | Padagis Israel |
| Ingredient: | betamethasone valerate |
| Patents: | 0 |
Pharmacology for NDA: 078337
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078337
Suppliers and Packaging for NDA: 078337
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 078337 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-053 | 45802-053-01 | 1 CAN in 1 CARTON (45802-053-01) / 50 g in 1 CAN |
| BETAMETHASONE VALERATE | betamethasone valerate | AEROSOL, FOAM;TOPICAL | 078337 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-053 | 45802-053-02 | 1 CAN in 1 CARTON (45802-053-02) / 100 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.12% | ||||
| Approval Date: | Nov 26, 2012 | TE: | AB | RLD: | No | ||||
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