Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083982
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPYLTHIOURACIL PROPYLTHIOURACIL 50MG TABLET;ORAL Discontinued None No No
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.

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