Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050169
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 SUSPENSION/DROPS;OPHTHALMIC Discontinued None No 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
12/18/1964 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
11/25/2003 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50169slr046_cortisporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50169slr046ltr.pdf
04/19/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/13/1995 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1982 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/26/1982 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1981 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/15/1981 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1980 SUPPL-35 Labeling

Label is not available on this site.

01/16/1981 SUPPL-34 Efficacy-New Indication

Label is not available on this site.

11/20/1972 SUPPL-31 Labeling

Label is not available on this site.

07/06/1972 SUPPL-30 Labeling

Label is not available on this site.

06/21/1972 SUPPL-28 Labeling

Label is not available on this site.

05/11/1971 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1970 SUPPL-24 Labeling

Label is not available on this site.

10/09/1970 SUPPL-23 Labeling

Label is not available on this site.

07/27/1970 SUPPL-22 Labeling

Label is not available on this site.

03/17/1969 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1969 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1969 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1967 SUPPL-16 Labeling

Label is not available on this site.

04/20/1967 SUPPL-15 Labeling

Label is not available on this site.

04/10/1967 SUPPL-14 Labeling

Label is not available on this site.

04/04/1967 SUPPL-13 Labeling

Label is not available on this site.

10/19/1966 SUPPL-12 Labeling

Label is not available on this site.

09/13/1966 SUPPL-10 Labeling

Label is not available on this site.

05/10/1994 SUPPL-9 Labeling

Label is not available on this site.

12/13/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1984 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1966 SUPPL-3 Labeling

Label is not available on this site.

09/30/1965 SUPPL-2 Labeling

Label is not available on this site.

03/30/1983 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/25/2003 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50169slr046_cortisporin_lbl.pdf

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