Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 002282
Company: ISO TEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INULIN AND SODIUM CHLORIDE INULIN 100MG/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
04/30/1940 ORIG-1 Approval Type 4 - New Combination 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
04/20/1999 SUPPL-16 Labeling

Label is not available on this site.

03/04/1998 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/31/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1991 SUPPL-8 Labeling

Label is not available on this site.

10/19/1987 SUPPL-7 Labeling

Label is not available on this site.

10/23/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1976 SUPPL-4 Labeling

Label is not available on this site.

07/22/1975 SUPPL-3 Unspecified

Label is not available on this site.

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