Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080515
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/20/1971 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/080515_cyanocobalamin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2016 SUPPL-201 Labeling-Package Insert

Label is not available on this site.

10/27/2000 SUPPL-200 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1998 SUPPL-199 Manufacturing (CMC)

Label is not available on this site.

09/08/1997 SUPPL-196 Manufacturing (CMC)

Label is not available on this site.

11/18/1993 SUPPL-195 Manufacturing (CMC)

Label is not available on this site.

04/05/1990 SUPPL-194 Labeling

Label is not available on this site.

05/09/1989 SUPPL-193 Labeling

Label is not available on this site.

04/26/1989 SUPPL-192 Labeling

Label is not available on this site.

04/26/1989 SUPPL-191 Labeling

Label is not available on this site.

04/03/1989 SUPPL-190 Labeling

Label is not available on this site.

11/03/1986 SUPPL-187 Manufacturing (CMC)

Label is not available on this site.

09/10/1986 SUPPL-185 Manufacturing (CMC)

Label is not available on this site.

11/03/1986 SUPPL-184 Manufacturing (CMC)

Label is not available on this site.

02/03/1983 SUPPL-182 Manufacturing (CMC)

Label is not available on this site.

CYANOCOBALAMIN

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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