Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050218
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTISPORIN HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM CREAM;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
04/16/1963 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
03/26/2013 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

12/20/2002 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50218slr051ltr.pdf
03/21/2001 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1999 SUPPL-47 Labeling

Label is not available on this site.

04/27/1982 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1982 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/06/1981 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1977 SUPPL-42 Labeling

Label is not available on this site.

05/01/1974 SUPPL-41 Labeling

Label is not available on this site.

04/24/1974 SUPPL-40 Labeling

Label is not available on this site.

03/08/1974 SUPPL-39 Labeling

Label is not available on this site.

10/04/1972 SUPPL-38 Labeling

Label is not available on this site.

07/27/1972 SUPPL-37 Labeling

Label is not available on this site.

07/25/1972 SUPPL-36 Labeling

Label is not available on this site.

06/21/1972 SUPPL-35 Labeling

Label is not available on this site.

03/22/1972 SUPPL-34 Labeling

Label is not available on this site.

05/11/1971 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/26/1970 SUPPL-32 Labeling

Label is not available on this site.

07/27/1970 SUPPL-31 Labeling

Label is not available on this site.

08/11/1970 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/12/1970 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1969 SUPPL-28 Labeling

Label is not available on this site.

04/25/1969 SUPPL-27 Labeling

Label is not available on this site.

03/04/1969 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/29/1968 SUPPL-25 Labeling

Label is not available on this site.

06/19/1967 SUPPL-24 Labeling

Label is not available on this site.

05/15/1967 SUPPL-23 Labeling

Label is not available on this site.

03/29/1967 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1967 SUPPL-21 Labeling

Label is not available on this site.

07/22/1966 SUPPL-20 Labeling

Label is not available on this site.

11/30/1966 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1965 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/12/1965 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1964 SUPPL-15 Labeling

Label is not available on this site.

05/08/1964 SUPPL-14 Labeling

Label is not available on this site.

05/08/1964 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1964 SUPPL-12 Labeling

Label is not available on this site.

09/04/1963 SUPPL-11 Labeling

Label is not available on this site.

07/24/1963 SUPPL-10 Labeling

Label is not available on this site.

07/17/1963 SUPPL-9 Labeling

Label is not available on this site.

07/24/1963 SUPPL-8 Labeling

Label is not available on this site.

04/23/1992 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1987 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1985 SUPPL-4 Labeling

Label is not available on this site.

08/09/1985 SUPPL-3 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English