Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087355
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN NITROGLYCERIN 2% OINTMENT;TRANSDERMAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/1981 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
10/05/2005 SUPPL-26 Labeling

Label is not available on this site.

08/06/2004 SUPPL-25 Labeling

Label is not available on this site.

08/31/1999 SUPPL-23 Labeling

Label is not available on this site.

06/09/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-19 Labeling

Label is not available on this site.

04/26/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/05/1993 SUPPL-15 Labeling

Label is not available on this site.

01/31/1992 SUPPL-14 Labeling

Label is not available on this site.

09/30/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/22/1991 SUPPL-12 Labeling

Label is not available on this site.

03/20/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/31/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/31/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/15/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/01/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/01/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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