Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050479
Company: MONARCH PHARMS

Products on NDA 050479

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B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OTIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1975	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
05/28/2021	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050479s020lbl.pdf
06/28/1999	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1999	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50479S015_Cortisporin.pdf
03/15/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/21/1996	SUPPL-12	Labeling		Label is not available on this site.
01/04/1980	SUPPL-11	Labeling		Label is not available on this site.
10/09/1979	SUPPL-10	Labeling		Label is not available on this site.
10/18/1976	SUPPL-9	Labeling		Label is not available on this site.
06/22/1976	SUPPL-8	Labeling		Label is not available on this site.
01/29/1976	SUPPL-7	Labeling		Label is not available on this site.
11/19/1987	SUPPL-6	Labeling		Label is not available on this site.
04/01/1987	SUPPL-5	Labeling		Label is not available on this site.
08/08/1986	SUPPL-4	Labeling		Label is not available on this site.
12/13/1985	SUPPL-3	Labeling		Label is not available on this site.
08/20/1984	SUPPL-2	Labeling		Label is not available on this site.
07/06/1983	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050479

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2021	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050479s020lbl.pdf