Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083982
Company: SUN PHARM INDUSTRIES

Products on ANDA 083982

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083982

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/1974	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/1998	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
06/05/1990	SUPPL-40	Labeling		Label is not available on this site.
10/28/1988	SUPPL-39	Labeling		Label is not available on this site.
02/22/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
04/06/1987	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
09/22/1986	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/08/1985	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
02/28/1983	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
02/28/1983	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.