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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083163
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 2MEQ/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
08/29/1975 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
06/18/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/19/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-23 Labeling

Label is not available on this site.

06/18/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/03/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/26/1992 SUPPL-16 Labeling

Label is not available on this site.

06/15/1992 SUPPL-15 Labeling

Label is not available on this site.

04/04/1991 SUPPL-14 Labeling

Label is not available on this site.

02/07/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/07/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/05/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/05/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/12/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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