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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008370
Company: ABBVIE

Products on NDA 008370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
BENTYL PRESERVATIVE FREE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/1952	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
01/11/2013	SUPPL-33	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-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf
02/02/2007	SUPPL-31	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
08/12/2002	SUPPL-30	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-370slr030ltr.pdf
06/23/2000	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/17/1999	SUPPL-28	Labeling		Label is not available on this site.
09/06/1996	SUPPL-27	Labeling		Label is not available on this site.
12/23/1991	SUPPL-26	Labeling		Label is not available on this site.
03/18/1991	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/1990	SUPPL-24	Labeling		Label is not available on this site.
01/04/1993	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/18/1988	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-18	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1984	SUPPL-17	Labeling		Label is not available on this site.
08/04/1989	SUPPL-13	Labeling		Label is not available on this site.

Labels for NDA 008370

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2013	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf
08/01/2011	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf
02/02/2007	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf

Therapeutic Equivalents for NDA 008370

BENTYL

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
BENTYL PRESERVATIVE FREE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208353	AM REGENT
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210979	FOSUN PHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210257	FRESENIUS KABI USA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206468	NEXUS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207076	SLATE RUN PHARMA
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040465	HIKMA

BENTYL PRESERVATIVE FREE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
BENTYL PRESERVATIVE FREE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208353	AM REGENT
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210979	FOSUN PHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210257	FRESENIUS KABI USA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206468	NEXUS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207076	SLATE RUN PHARMA
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040465	HIKMA

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