Details for New Drug Application (NDA): 076215
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NDA 076215 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Anda Repository, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tasman Pharma, and Zydus Lifesciences, and is included in forty-seven NDAs. It is available from twenty-two suppliers. Additional details are available on the BETAMETHASONE DIPROPIONATE profile page.
The generic ingredient in BETAMETHASONE DIPROPIONATE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
The generic ingredient in BETAMETHASONE DIPROPIONATE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 076215
| Tradename: | BETAMETHASONE DIPROPIONATE |
| Applicant: | Fougera Pharms |
| Ingredient: | betamethasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 076215
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076215
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 076215 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0265 | 0168-0265-15 | 15 g in 1 TUBE (0168-0265-15) |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 076215 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0265 | 0168-0265-50 | 50 g in 1 TUBE (0168-0265-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM, AUGMENTED;TOPICAL | Strength | EQ 0.05% BASE | ||||
| Approval Date: | Dec 9, 2003 | TE: | AB | RLD: | No | ||||
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