Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050202
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROMYCETIN HYDROCORTISONE CHLORAMPHENICOL; HYDROCORTISONE ACETATE 12.5MG/VIAL;25MG/VIAL FOR SUSPENSION;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
12/09/1953 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
09/28/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/07/1982 SUPPL-16 Labeling

Label is not available on this site.

12/02/1980 SUPPL-15 Labeling

Label is not available on this site.

05/29/1980 SUPPL-14 Labeling

Label is not available on this site.

08/03/1978 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/23/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/16/1956 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/12/1956 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/25/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/29/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/17/1984 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/08/1954 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/11/1954 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1983 SUPPL-1 Labeling

Label is not available on this site.

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