Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017476
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SLOW-K POTASSIUM CHLORIDE 8MEQ TABLET, 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
04/25/1975 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/24/2004 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf
11/24/2004 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf
04/28/1999 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1996 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/30/1992 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1991 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1989 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1988 SUPPL-37 Labeling

Label is not available on this site.

10/31/1986 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1985 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1984 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1983 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1982 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1981 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/14/1981 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/21/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1980 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1980 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1982 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/04/1979 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1979 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1979 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1980 SUPPL-18 Labeling

Label is not available on this site.

07/08/1982 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1977 SUPPL-15 Labeling

Label is not available on this site.

04/07/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/29/1979 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1977 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/08/1977 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1976 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/29/1976 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/01/1976 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/01/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1976 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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