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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209827
Company: MACLEODS PHARMS LTD

Products on ANDA 209827

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 209827

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209827

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	040547	AIPING PHARM INC
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	202068	RISING
METHIMAZOLE	METHIMAZOLE	5MG	TABLET;ORAL	Prescription	No	AB	218830	SQUARE PHARMS PLC

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	040547	AIPING PHARM INC
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	202068	RISING
METHIMAZOLE	METHIMAZOLE	10MG	TABLET;ORAL	Prescription	No	AB	218830	SQUARE PHARMS PLC

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