Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019532
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYKROX METOLAZONE 0.5MG TABLET;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
10/30/1987 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019532_Mycrox_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf
10/29/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf
04/17/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/2001 SUPPL-12 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf
11/01/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1999 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/16/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1996 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/1995 SUPPL-6 Labeling

Label is not available on this site.

01/13/1994 SUPPL-5 Labeling

Label is not available on this site.

01/13/1993 SUPPL-4 Labeling

Label is not available on this site.

09/13/1991 SUPPL-3 Labeling

Label is not available on this site.

09/20/1988 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19532s12lbl.pdf

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