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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050201
Company: PARKEDALE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPHTHOCORT CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE 10MG/GM;5MG/GM;10,000 UNITS/GM OINTMENT;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
06/25/1958 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
08/27/1996 SUPPL-26 Labeling

Label is not available on this site.
03/25/1988 SUPPL-25 Labeling

Label is not available on this site.
04/19/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
07/07/1982 SUPPL-23 Labeling

Label is not available on this site.
12/12/1980 SUPPL-22 Labeling

Label is not available on this site.
12/08/1980 SUPPL-21 Labeling

Label is not available on this site.
01/22/1980 SUPPL-19 Labeling

Label is not available on this site.
12/20/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
08/29/1978 SUPPL-17 Labeling

Label is not available on this site.
06/05/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
07/18/1973 SUPPL-15 Labeling

Label is not available on this site.
08/30/1972 SUPPL-14 Labeling

Label is not available on this site.
08/30/1972 SUPPL-13 Labeling

Label is not available on this site.
11/09/1970 SUPPL-12 Labeling

Label is not available on this site.
12/10/1963 SUPPL-11 Labeling

Label is not available on this site.
05/19/1961 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/19/1961 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/17/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
09/29/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
11/08/1988 SUPPL-4 Labeling

Label is not available on this site.
08/15/1983 SUPPL-3 Labeling

Label is not available on this site.
07/22/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/19/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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