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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050416
Company: CASPER PHARMA LLC

Products on NDA 050416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTISPORIN	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/1971	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
03/22/2004	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50416slr015_cortisporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50416slr015ltr.pdf
04/19/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/23/1998	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/1995	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
02/09/1995	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/22/1993	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1993	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/10/1994	SUPPL-6	Labeling		Label is not available on this site.

Labels for NDA 050416

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2004	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50416slr015_cortisporin_lbl.pdf

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