Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074852
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;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
10/10/1997 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
08/30/2007 SUPPL-14 Labeling

Label is not available on this site.

03/12/2007 SUPPL-13 Labeling

Label is not available on this site.

12/24/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

10/11/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/07/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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