Details for New Drug Application (NDA): 085998
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NDA 085998 describes HYDROXOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Actavis, and Watson Labs, and is included in three NDAs. It is available from one supplier. Additional details are available on the HYDROXOCOBALAMIN profile page.
The generic ingredient in HYDROXOCOBALAMIN is hydroxocobalamin. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.
The generic ingredient in HYDROXOCOBALAMIN is hydroxocobalamin. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.
Summary for 085998
| Tradename: | HYDROXOCOBALAMIN |
| Applicant: | Actavis |
| Ingredient: | hydroxocobalamin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 085998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXOCOBALAMIN | hydroxocobalamin | INJECTABLE;INJECTION | 085998 | ANDA | Actavis Pharma, Inc. | 0591-2888 | 0591-2888-30 | 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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