Details for New Drug Application (NDA): 090747
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NDA 090747 describes BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Am Regent and Hikma and is included in two NDAs. It is available from three suppliers. Additional details are available on the BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE profile page.
The generic ingredient in BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE is betamethasone acetate; betamethasone sodium phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betamethasone acetate; betamethasone sodium phosphate profile page.
The generic ingredient in BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE is betamethasone acetate; betamethasone sodium phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betamethasone acetate; betamethasone sodium phosphate profile page.
Summary for 090747
| Tradename: | BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE |
| Applicant: | Am Regent |
| Ingredient: | betamethasone acetate; betamethasone sodium phosphate |
| Patents: | 0 |
Pharmacology for NDA: 090747
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 090747
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | betamethasone acetate; betamethasone sodium phosphate | INJECTABLE;INJECTION | 090747 | ANDA | American Regent, Inc. | 0517-0720 | 0517-0720-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE |
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | betamethasone acetate; betamethasone sodium phosphate | INJECTABLE;INJECTION | 090747 | ANDA | American Regent, Inc. | 0517-0791 | 0517-0791-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0791-01) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3MG/ML;EQ 3MG BASE/ML | ||||
| Approval Date: | Jul 31, 2009 | TE: | AB | RLD: | No | ||||
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