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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019532
Company: CHARTWELL MOLECULAR

Products on NDA 019532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYKROX	METOLAZONE	0.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019532

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.

Labels for NDA 019532

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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