Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080737
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription AP Yes 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
04/26/1972 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
06/27/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2002 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/14/2001 SUPPL-21 Labeling

Label is not available on this site.

05/14/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1999 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/11/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-15 Labeling

Label is not available on this site.

09/17/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/28/1989 SUPPL-12 Labeling

Label is not available on this site.

07/29/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/29/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/20/1988 SUPPL-9 Labeling

Label is not available on this site.

01/17/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/20/1988 SUPPL-5 Labeling

Label is not available on this site.

08/16/1982 SUPPL-3 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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