Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040161
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB 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
10/01/1996 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
03/05/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/11/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/17/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-2 Labeling

Label is not available on this site.

10/10/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DICYCLOMINE HYDROCHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENTYL DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 007409 ALLERGAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040161 HIKMA PHARMS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040230 LANNETT
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040317 MYLAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 085223 WATSON LABS

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