Details for New Drug Application (NDA): 077111
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NDA 077111 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Chartwell Molecular, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Lupin Ltd, Tp Anda Holdings, and Zydus Lifesciences, and is included in forty-eight NDAs. It is available from twenty-three 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-six 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-six suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 077111
| Tradename: | BETAMETHASONE DIPROPIONATE |
| Applicant: | Fougera Pharms |
| Ingredient: | betamethasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 077111
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077111
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 077111 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0267 | 0168-0267-30 | 30 mL in 1 BOTTLE (0168-0267-30) |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 077111 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0267 | 0168-0267-60 | 60 mL in 1 BOTTLE (0168-0267-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION, AUGMENTED;TOPICAL | Strength | EQ 0.05% BASE | ||||
| Approval Date: | May 21, 2007 | TE: | AB | RLD: | No | ||||
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