Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006799
Company: BRISTOL MYERS SQUIBB

Products on NDA 006799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUBRAMIN PC	CYANOCOBALAMIN	0.1MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
RUBRAMIN PC	CYANOCOBALAMIN	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
RUBRAMIN PC	CYANOCOBALAMIN	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1950	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/1995	SUPPL-15	Labeling		Label is not available on this site.
12/07/2007	SUPPL-14	Labeling		Label is not available on this site.
10/14/1987	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1986	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
10/01/1984	SUPPL-11	Labeling		Label is not available on this site.
07/09/1984	SUPPL-10	Labeling		Label is not available on this site.
07/31/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/15/1983	SUPPL-8	Labeling		Label is not available on this site.
08/26/1980	SUPPL-7	Labeling		Label is not available on this site.
01/19/1979	SUPPL-6	Labeling		Label is not available on this site.
12/07/2007	SUPPL-4	Labeling		Label is not available on this site.