Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050479
Company: MONARCH PHARMS
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B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OTIC Discontinued None Yes No
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
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.

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