Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050156
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROMYCETIN CHLORAMPHENICOL 1% 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
06/01/1951 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/1998 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/03/1999 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1999 SUPPL-38 Labeling

Label is not available on this site.

08/27/1986 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/08/1983 SUPPL-35 Labeling

Label is not available on this site.

08/27/1996 SUPPL-34 Labeling

Label is not available on this site.

04/19/1983 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/24/1982 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/08/1981 SUPPL-31 Labeling

Label is not available on this site.

12/30/1979 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/19/1977 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/23/1977 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/11/1973 SUPPL-27 Labeling

Label is not available on this site.

03/23/1973 SUPPL-26 Labeling

Label is not available on this site.

08/09/1972 SUPPL-25 Labeling

Label is not available on this site.

03/23/1973 SUPPL-24 Labeling

Label is not available on this site.

06/27/1972 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1972 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/12/1972 SUPPL-21 Labeling

Label is not available on this site.

07/12/1971 SUPPL-20 Labeling

Label is not available on this site.

05/03/1971 SUPPL-19 Labeling

Label is not available on this site.

10/28/1969 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1964 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1963 SUPPL-16 Labeling

Label is not available on this site.

12/10/1963 SUPPL-15 Labeling

Label is not available on this site.

08/26/1963 SUPPL-14 Labeling

Label is not available on this site.

06/11/1963 SUPPL-13 Labeling

Label is not available on this site.

04/08/1963 SUPPL-12 Labeling

Label is not available on this site.

07/26/1962 SUPPL-11 Labeling

Label is not available on this site.

12/01/1961 SUPPL-10 Labeling

Label is not available on this site.

12/01/1961 SUPPL-9 Labeling

Label is not available on this site.

05/19/1961 SUPPL-8 Labeling

Label is not available on this site.

05/19/1961 SUPPL-7 Labeling

Label is not available on this site.

04/17/1957 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/17/1955 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/30/1953 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1952 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1983 SUPPL-2 Manufacturing (CMC)-Control

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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