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Details for New Drug Application (NDA): 085998

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NDA 085998 describes HYDROXOCOBALAMIN, which is a drug marketed by Abraxis Pharm and Watson Labs and is included in three NDAs. It is available from two suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.

Summary for NDA: 085998

Watson Labs
Formulation / Manufacturing:see details

Pharmacology for NDA: 085998

Suppliers and Packaging for NDA: 085998

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 085998 ANDA Watson Laboratories, Inc. 0591-2888 0591-2888-30 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) > 30 mL in 1 VIAL, MULTI-DOSE
INJECTABLE;INJECTION 085998 ANDA REMEDYREPACK INC. 52125-799 52125-799-01 1 VIAL, MULTI-DOSE in 1 CARTON (52125-799-01) > 30 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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