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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087569
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE SODIUM SUCCINATE HYDROCORTISONE SODIUM SUCCINATE EQ 1GM BASE/VIAL 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
05/28/1981 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
05/05/1988 SUPPL-9 Labeling

Label is not available on this site.

11/03/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/01/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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