Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050168
Company: MONARCH PHARMS
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;5,000 UNITS/GM OINTMENT;TOPICAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/26/1957 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
11/21/2003 SUPPL-78 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50168slr078ltr.pdf
08/13/2001 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

05/28/1999 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

11/04/1998 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1999 SUPPL-73 Labeling

Label is not available on this site.

03/26/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/20/1981 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

06/19/1978 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1977 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/13/1977 SUPPL-65 Labeling

Label is not available on this site.

06/16/1974 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

04/24/1974 SUPPL-63 Labeling

Label is not available on this site.

02/12/1974 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/17/1972 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

10/16/1972 SUPPL-60 Labeling

Label is not available on this site.

07/05/1972 SUPPL-59 Labeling

Label is not available on this site.

06/23/1972 SUPPL-58 Labeling

Label is not available on this site.

05/10/1971 SUPPL-57 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/23/1973 SUPPL-56 Labeling

Label is not available on this site.

07/24/1970 SUPPL-55 Labeling

Label is not available on this site.

06/15/1970 SUPPL-54 Labeling

Label is not available on this site.

05/25/1970 SUPPL-53 Labeling

Label is not available on this site.

08/11/1970 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/17/1970 SUPPL-51 Labeling

Label is not available on this site.

04/07/1970 SUPPL-50 Labeling

Label is not available on this site.

07/08/1969 SUPPL-49 Labeling

Label is not available on this site.

03/04/1969 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

08/14/1968 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1968 SUPPL-45 Labeling

Label is not available on this site.

12/18/1967 SUPPL-44 Labeling

Label is not available on this site.

08/11/1967 SUPPL-43 Labeling

Label is not available on this site.

07/20/1967 SUPPL-42 Labeling

Label is not available on this site.

07/20/1967 SUPPL-41 Labeling

Label is not available on this site.

04/06/1967 SUPPL-40 Labeling

Label is not available on this site.

03/03/1967 SUPPL-39 Labeling

Label is not available on this site.

03/03/1967 SUPPL-38 Labeling

Label is not available on this site.

02/24/1967 SUPPL-37 Labeling

Label is not available on this site.

03/20/1967 SUPPL-36 Labeling

Label is not available on this site.

02/10/1967 SUPPL-35 Labeling

Label is not available on this site.

01/20/1967 SUPPL-34 Labeling

Label is not available on this site.

01/13/1967 SUPPL-32 Labeling

Label is not available on this site.

11/03/1966 SUPPL-30 Labeling

Label is not available on this site.

08/26/1966 SUPPL-28 Labeling

Label is not available on this site.

05/12/1966 SUPPL-25 Labeling

Label is not available on this site.

06/08/1965 SUPPL-23 Labeling

Label is not available on this site.

04/06/1965 SUPPL-22 Labeling

Label is not available on this site.

03/22/1965 SUPPL-21 Labeling

Label is not available on this site.

01/12/1965 SUPPL-20 Labeling

Label is not available on this site.

01/11/1965 SUPPL-19 Labeling

Label is not available on this site.

01/06/1965 SUPPL-18 Labeling

Label is not available on this site.

12/22/1964 SUPPL-17 Labeling

Label is not available on this site.

10/17/1963 SUPPL-15 Labeling

Label is not available on this site.

10/04/1963 SUPPL-14 Labeling

Label is not available on this site.

07/24/1963 SUPPL-12 Labeling

Label is not available on this site.

06/01/1962 SUPPL-10 Labeling

Label is not available on this site.

09/22/1993 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1962 SUPPL-8 Labeling

Label is not available on this site.

05/24/1962 SUPPL-7 Labeling

Label is not available on this site.

04/07/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-5 Labeling

Label is not available on this site.

12/04/1985 SUPPL-4 Labeling

Label is not available on this site.

09/06/1960 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/25/1984 SUPPL-2 Labeling

Label is not available on this site.

07/06/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2003 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf

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