Details for New Drug Application (NDA): 218289
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NDA 218289 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Chartwell Molecular, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Sun Pharma Canada, 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, Tp Anda Holdings, and Zydus Lifesciences, and is included in forty-seven 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 218289
| Tradename: | BETAMETHASONE DIPROPIONATE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | betamethasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 218289
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 218289
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | OINTMENT, AUGMENTED;TOPICAL | 218289 | ANDA | Burel Pharmaceuticals, LLC | 35573-107 | 35573-107-15 | 1 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBE |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | OINTMENT, AUGMENTED;TOPICAL | 218289 | ANDA | Burel Pharmaceuticals, LLC | 35573-107 | 35573-107-49 | 1 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT, AUGMENTED;TOPICAL | Strength | EQ 0.05% BASE | ||||
| Approval Date: | Apr 10, 2024 | TE: | AB | RLD: | No | ||||
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