Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017386
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZAROXOLYN METOLAZONE 2.5MG TABLET;ORAL Discontinued None Yes No
ZAROXOLYN METOLAZONE 5MG TABLET;ORAL Discontinued None Yes No
ZAROXOLYN METOLAZONE 10MG TABLET;ORAL Discontinued None Yes 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
11/27/1973 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/24/2019 SUPPL-43 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017386s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017386Orig1s043ltr.pdf
03/30/2015 SUPPL-40 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/017386Orig1s040.pdf
11/22/2013 SUPPL-39 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017386Orig1s039.pdf
08/19/2003 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017386s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf
10/29/2002 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf
04/15/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/2001 SUPPL-32 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf
10/18/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-30 Labeling

Label is not available on this site.

07/14/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1997 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/1995 SUPPL-26 Labeling

Label is not available on this site.

05/04/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1994 SUPPL-24 Labeling

Label is not available on this site.

01/13/1993 SUPPL-23 Labeling

Label is not available on this site.

10/10/1989 SUPPL-22 Labeling

Label is not available on this site.

12/09/1988 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1988 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1985 SUPPL-18 Labeling

Label is not available on this site.

02/07/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1987 SUPPL-15 Labeling

Label is not available on this site.

02/18/1983 SUPPL-14 Labeling

Label is not available on this site.

07/15/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1982 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/02/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1989 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1980 SUPPL-8 Labeling

Label is not available on this site.

05/11/1977 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/25/1978 SUPPL-5 Labeling

Label is not available on this site.

04/25/1978 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/24/2019 SUPPL-43 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017386s043lbl.pdf
08/19/2003 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017386s036lbl.pdf
08/10/2001 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf

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