Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085998
Company: ACTAVIS

Products on ANDA 085998

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXOCOBALAMIN	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085998

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
02/11/1992	SUPPL-107	Labeling		Label is not available on this site.
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.