Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010562
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDELTRA-TBA PREDNISOLONE TEBUTATE 20MG/ML INJECTABLE;INJECTION 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
07/25/1956 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/26/1993 SUPPL-29 Labeling

Label is not available on this site.

12/11/1989 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1989 SUPPL-23 Labeling

Label is not available on this site.

03/04/1982 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1979 SUPPL-18 Labeling

Label is not available on this site.

07/02/1980 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/08/1979 SUPPL-16 Labeling

Label is not available on this site.

08/08/1979 SUPPL-15 Labeling

Label is not available on this site.

08/08/1979 SUPPL-14 Labeling

Label is not available on this site.

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