Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074051
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG 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
03/31/1993 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
09/24/1997 SUPPL-9 Labeling

Label is not available on this site.

06/27/1997 SUPPL-8 Labeling

Label is not available on this site.

08/26/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/08/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/08/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/08/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/19/1995 SUPPL-3 Labeling

Label is not available on this site.

09/22/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/09/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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