Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018749
Company: MISSION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LITHOSTAT ACETOHYDROXAMIC ACID 250MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/31/1983 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/19/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-6 Labeling

Label is not available on this site.

08/06/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1984 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1983 SUPPL-1 Labeling

Label is not available on this site.

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