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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050526
Company: WESTWOOD SQUIBB

Products on NDA 050526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STATICIN	ERYTHROMYCIN	1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/1980	ORIG-1	Approval	Type 3 - New Dosage Form	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
12/15/2002	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50526slr010ltr.pdf
03/13/1995	SUPPL-9	Labeling		Label is not available on this site.
03/24/1982	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/02/1981	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/02/1981	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/14/1981	SUPPL-5	Labeling		Label is not available on this site.
06/12/1980	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/12/1980	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/10/1986	SUPPL-2	Labeling		Label is not available on this site.
12/23/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2002	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.pdf

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