Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208867
Company: MACLEODS PHARMS LTD

Products on ANDA 208867

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208867

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2024	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208867

PROPYLTHIOURACIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	No	AB	208867	MACLEODS PHARMS LTD
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	Yes	AB	006188	PH HEALTH