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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040411
Company: CHARTWELL RX

Products on ANDA 040411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	AB	No	No
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40411ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
01/15/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
07/11/2012	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/22/2011	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/28/2011	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/08/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040411

METHIMAZOLE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	218149	BIONPHARMA
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	040411	CHARTWELL RX
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	040734	HERITAGE PHARMA
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	209827	MACLEODS PHARMS LTD
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	040350	MYLAN
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	040547	QINGDAO BAHEAL PHARM
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	202068	RISING

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	218149	BIONPHARMA
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	040411	CHARTWELL RX
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	040734	HERITAGE PHARMA
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	209827	MACLEODS PHARMS LTD
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	040350	MYLAN
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	040547	QINGDAO BAHEAL PHARM
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	202068	RISING

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