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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076175
Company: CHARTWELL RX

Products on ANDA 076175

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076175

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76175_Mefloquine Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76175.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076175_mefloquine_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2016	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
07/26/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076175s030lbl.pdf
09/02/2011	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/076175s026lbl.pdf
10/19/2009	SUPPL-25	Labeling-Patient Package Insert		Label is not available on this site.
01/15/2009	SUPPL-22	Labeling		Label is not available on this site.
09/18/2008	SUPPL-21	Labeling		Label is not available on this site.
04/09/2004	SUPPL-10	Labeling		Label is not available on this site.
10/24/2003	SUPPL-8	Labeling		Label is not available on this site.
10/29/2002	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 076175

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076175s030lbl.pdf
09/02/2011	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/076175s026lbl.pdf
02/20/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76175_Mefloquine Hydrochloride_Prntlbl.pdf

Therapeutic Equivalents for ANDA 076175

MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	No	AB	076392	BARR
MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	No	AB	076175	CHARTWELL RX

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