Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085998
Company: ACTAVIS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXOCOBALAMIN HYDROXOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription None 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
08/16/1978 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
07/08/2002 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2001 SUPPL-90 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/06/2002 SUPPL-89 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/04/2001 SUPPL-88 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/04/2001 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2002 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

09/15/2000 SUPPL-85 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/29/2000 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/2000 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/2000 SUPPL-81 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/22/1999 SUPPL-80 Labeling

Label is not available on this site.

11/22/1999 SUPPL-79 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1999 SUPPL-77 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/04/1999 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

02/02/1999 SUPPL-75 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/29/1997 SUPPL-74 Labeling

Label is not available on this site.

12/04/1996 SUPPL-73 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/29/1997 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

02/11/1992 SUPPL-71 Labeling

Label is not available on this site.

05/09/1989 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

05/09/1989 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

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