Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089567
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-EST ESTROPIPATE 0.75MG 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
02/27/1991 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
07/21/2004 SUPPL-20 Labeling

Label is not available on this site.

04/07/2005 SUPPL-17 Labeling

Label is not available on this site.

06/11/2003 SUPPL-15 Labeling

Label is not available on this site.

03/19/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

03/19/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

06/12/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/08/1996 SUPPL-6 Labeling

Label is not available on this site.

02/22/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/23/1993 SUPPL-3 Labeling

Label is not available on this site.

06/21/1993 SUPPL-2 Labeling

Label is not available on this site.

04/19/1993 SUPPL-1 Labeling

Label is not available on this site.

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