Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005963
Company: SCHERING

Products on NDA 005963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM SULAMYD	SULFACETAMIDE SODIUM	10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No
SODIUM SULAMYD	SULFACETAMIDE SODIUM	10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No
SODIUM SULAMYD	SULFACETAMIDE SODIUM	30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/1946	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2001	SUPPL-18	Labeling		Label is not available on this site.
09/17/2001	SUPPL-13	Labeling		Label is not available on this site.
10/01/1986	SUPPL-5	Labeling		Label is not available on this site.
09/17/2001	SUPPL-4	Labeling		Label is not available on this site.
09/17/2001	SUPPL-3	Labeling		Label is not available on this site.