Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050205
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROMYCETIN CHLORAMPHENICOL 0.5% SOLUTION/DROPS;OTIC 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
03/30/1953 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
04/23/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-26 Labeling

Label is not available on this site.

11/21/1996 SUPPL-25 Labeling

Label is not available on this site.

05/29/1981 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/08/1981 SUPPL-23 Labeling

Label is not available on this site.

01/22/1980 SUPPL-22 Labeling

Label is not available on this site.

08/03/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/23/1977 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/13/2009 SUPPL-19 Labeling

Label is not available on this site.

08/29/1966 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/10/1974 SUPPL-17 Labeling

Label is not available on this site.

05/03/1974 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1974 SUPPL-15 Labeling

Label is not available on this site.

03/13/2009 SUPPL-14 Labeling

Label is not available on this site.

04/22/1971 SUPPL-13 Labeling

Label is not available on this site.

04/06/1969 SUPPL-12 Labeling

Label is not available on this site.

12/10/1963 SUPPL-11 Labeling

Label is not available on this site.

06/11/1963 SUPPL-10 Labeling

Label is not available on this site.

03/13/2009 SUPPL-9 Labeling

Label is not available on this site.

07/26/1962 SUPPL-8 Labeling

Label is not available on this site.

05/19/1961 SUPPL-7 Labeling

Label is not available on this site.

06/18/1954 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/07/1953 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1953 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1988 SUPPL-2 Labeling

Label is not available on this site.

09/25/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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