Details for New Drug Application (NDA): 018861
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NDA 018861 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 018861
| Tradename: | BETAMETHASONE VALERATE |
| Applicant: | Fougera Pharms Inc |
| Ingredient: | betamethasone valerate |
| Patents: | 0 |
Pharmacology for NDA: 018861
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 018861
Suppliers and Packaging for NDA: 018861
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | betamethasone valerate | CREAM;TOPICAL | 018861 | NDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0040 | 0168-0040-15 | 15 g in 1 TUBE (0168-0040-15) |
| BETAMETHASONE VALERATE | betamethasone valerate | CREAM;TOPICAL | 018861 | NDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0040 | 0168-0040-46 | 45 g in 1 TUBE (0168-0040-46) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 0.1% BASE | ||||
| Approval Date: | Aug 31, 1983 | TE: | AB | RLD: | Yes | ||||
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