Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020092
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILACOR XR DILTIAZEM HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
DILACOR XR DILTIAZEM HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
DILACOR XR DILTIAZEM HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No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
05/29/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020092s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020092s017ltr.pdf
06/08/2010 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020092s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020092s016ltr.pdf
12/12/2003 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20092slr015ltr.pdf
08/07/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/28/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/20/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/02/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/09/1995 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

12/06/1993 SUPPL-4 Labeling

Label is not available on this site.

06/19/1997 SUPPL-3 Labeling

Label is not available on this site.

10/15/1992 SUPPL-2 Labeling

Label is not available on this site.

10/02/1992 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020092s017lbl.pdf
06/08/2010 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020092s016lbl.pdf

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