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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007961
Company: APTALIS PHARMA US

Products on NDA 007961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1951	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/01/2011	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf
02/02/2007	SUPPL-26	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-25	Labeling		Label is not available on this site.
09/09/1996	SUPPL-24	Labeling		Label is not available on this site.
09/25/1990	SUPPL-23	Labeling		Label is not available on this site.
01/04/1993	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/06/1987	SUPPL-21	Labeling		Label is not available on this site.
06/12/1985	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
05/13/1985	SUPPL-19	Labeling		Label is not available on this site.
10/15/1984	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1984	SUPPL-16	Labeling		Label is not available on this site.
08/04/1989	SUPPL-11	Labeling		Label is not available on this site.

Labels for NDA 007961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2011	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf
02/02/2007	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf

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