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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040350
Company: MYLAN

Products on ANDA 040350

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	Yes
METHIMAZOLE	METHIMAZOLE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040350

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40350ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040350.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/18/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
01/15/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
07/11/2012	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf
09/28/2001	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/10/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/2001	SUPPL-4	Labeling		Label is not available on this site.
06/07/2001	SUPPL-3	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf
06/07/2001	SUPPL-2	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf
06/07/2001	SUPPL-1	Manufacturing (CMC)-New Strength	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf

Labels for ANDA 040350

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2012	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf

Therapeutic Equivalents for ANDA 040350

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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