Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084285
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;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
09/30/1974 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
04/30/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/30/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/29/2008 SUPPL-13 Labeling

Label is not available on this site.

02/29/2008 SUPPL-12 Labeling

Label is not available on this site.

09/07/2007 SUPPL-11 Labeling

Label is not available on this site.

08/10/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

08/07/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-6 Labeling

Label is not available on this site.

10/03/1996 SUPPL-4 Labeling

Label is not available on this site.

04/17/1996 SUPPL-3 Labeling

Label is not available on this site.

03/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENTYL DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription Yes AB 007409 ALLERGAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 084285 LANNETT
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 040319 MYLAN
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 085082 WATSON LABS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 040204 WEST WARD

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