Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050416
Company: CASPER PHARMA LLC
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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;OPHTHALMIC Discontinued None Yes No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
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.

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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