Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087584
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-19 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/22/1991 SUPPL-16 Labeling

Label is not available on this site.

05/06/1991 SUPPL-15 Labeling

Label is not available on this site.

07/29/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/02/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/12/1991 SUPPL-10 Labeling

Label is not available on this site.

01/13/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/13/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/17/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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