Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070980
Company: NESHER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL 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
02/17/1987 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
03/13/2002 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/2000 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

11/30/2000 SUPPL-21 Labeling

Label is not available on this site.

11/30/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/30/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/30/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/16/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/19/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/22/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/28/1992 SUPPL-11 Labeling

Label is not available on this site.

02/28/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/28/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/28/1991 SUPPL-8 Labeling

Label is not available on this site.

02/15/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/06/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/25/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/22/1989 SUPPL-3 Labeling

Label is not available on this site.

12/22/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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