Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080557
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYANOCOBALAMIN CYANOCOBALAMIN 0.1MG/ML INJECTABLE;INJECTION Discontinued None No No
VIBISONE CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/20/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2005 SUPPL-32 Labeling

Label is not available on this site.

01/08/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/23/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/25/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-24 Labeling

Label is not available on this site.

09/16/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/15/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/17/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/17/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

CYANOCOBALAMIN

There are no Therapeutic Equivalents.

VIBISONE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 080737 AM REGENT
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 204829 MYLAN LABS LTD
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 206503 SOMERSET THERAPS LLC
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 209429 SOMERSET THERAPS LLC
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 209255 VITRUVIAS THERAP
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 080515 WEST-WARD PHARMS INT
VIBISONE CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 080557 FRESENIUS KABI USA

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