Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040465
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/30/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2018 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/29/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/10/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/05/2007 SUPPL-2 Labeling

Label is not available on this site.

DICYCLOMINE HYDROCHLORIDE (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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