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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020092
Company: ALLERGAN

Products on NDA 020092

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DILACOR XR	DILTIAZEM HYDROCHLORIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
DILACOR XR	DILTIAZEM HYDROCHLORIDE	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
DILACOR XR	DILTIAZEM HYDROCHLORIDE	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020092

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.

Labels for NDA 020092

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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