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Details for New Drug Application (NDA): 080557

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NDA 080557 describes VIBISONE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from five suppliers. Additional details are available on the VIBISONE profile page.

The generic ingredient in VIBISONE is cyanocobalamin. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

Summary for NDA: 080557

Fresenius Kabi Usa

Pharmacology for NDA: 080557

Ingredient-typeVitamin B 12

Suppliers and Packaging for NDA: 080557

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 080557 ANDA RX PHARMA-PACK, INC. 49836-527 49836-527-01 1 KIT in 1 CARTON (49836-527-01) * 1 mL in 1 VIAL, MULTI-DOSE * .55 mL in 1 POUCH
INJECTABLE;INJECTION 080557 ANDA APP Pharmaceuticals, LLC 63323-044 63323-044-01 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) > 1 mL in 1 VIAL, MULTI-DOSE

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

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

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