Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008370
Company: ALLERGAN
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
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.

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

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 ALLERGAN
BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 008370 ALLERGAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207084 AKORN INC
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 210788 CUSTOPHARM INC
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 PHARMS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207076 SLATE
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 212058 SUNGEN PHARMA
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 040465 WEST-WARD PHARMS INT

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 ALLERGAN
BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 008370 ALLERGAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207084 AKORN INC
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 210788 CUSTOPHARM INC
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 PHARMS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207076 SLATE
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 212058 SUNGEN PHARMA
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 040465 WEST-WARD PHARMS INT

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