Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080660
Company: MIZA PHARMS USA

Products on ANDA 080660

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCUSULF-10	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No
OCUSULF-30	SULFACETAMIDE SODIUM	30%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080660

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/1972	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
02/13/1996	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-45	Labeling		Label is not available on this site.
05/06/1993	SUPPL-44	Labeling		Label is not available on this site.
07/07/1992	SUPPL-43	Labeling		Label is not available on this site.
07/07/1992	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
04/04/1990	SUPPL-41	Labeling		Label is not available on this site.
06/19/1985	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
08/20/1985	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
12/13/1984	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
02/07/1984	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.