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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007409
Company: ALLERGAN

Products on NDA 007409

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENTYL	DICYCLOMINE HYDROCHLORIDE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1950	ORIG-1	Approval	Type 1 - New Molecular Entity	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
01/11/2013	SUPPL-42	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf
08/01/2011	SUPPL-41	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf
02/02/2007	SUPPL-40	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf
08/17/1999	SUPPL-39	Labeling		Label is not available on this site.
09/09/1996	SUPPL-38	Labeling		Label is not available on this site.
10/29/1991	SUPPL-36	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/24/1992	SUPPL-35	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/25/1990	SUPPL-34	Labeling		Label is not available on this site.
01/04/1993	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
06/15/1989	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
03/15/1990	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/06/1987	SUPPL-29	Labeling		Label is not available on this site.
06/12/1985	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
05/13/1985	SUPPL-27	Labeling		Label is not available on this site.
09/28/1987	SUPPL-26	Labeling		Label is not available on this site.
10/15/1984	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1984	SUPPL-24	Labeling		Label is not available on this site.
08/04/1989	SUPPL-16	Labeling		Label is not available on this site.

Labels for NDA 007409

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2013	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf
08/01/2011	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf
02/02/2007	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf

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