Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089169
Company: DR REDDYS

Products on ANDA 089169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/1986	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
12/02/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/19/1999	SUPPL-18	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-17	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/15/1997	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/04/1996	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/17/1995	SUPPL-14	Labeling		Label is not available on this site.
02/16/1994	SUPPL-13	Labeling		Label is not available on this site.
12/13/1993	SUPPL-12	Labeling		Label is not available on this site.
09/23/1993	SUPPL-11	Labeling		Label is not available on this site.
08/01/1988	SUPPL-8	Bioequivalence		Label is not available on this site.
08/02/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/02/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/15/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/19/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.