Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084751
Company: SAVAGE LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILOR-400 DYPHYLLINE 400MG 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
08/16/1976 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
12/15/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/02/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/28/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/28/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/13/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/13/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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