Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087585
Company: LUITPOLD
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
06/30/1981 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
11/07/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-19 Labeling

Label is not available on this site.

11/22/1991 SUPPL-18 Labeling

Label is not available on this site.

02/04/1991 SUPPL-17 Labeling

Label is not available on this site.

07/29/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/18/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/03/1988 SUPPL-13 Labeling

Label is not available on this site.

01/13/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/13/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/19/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/19/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/13/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/16/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/22/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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