Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040230
Company: LANNETT
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
02/26/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40230_Dicyclomine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40230ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040230_dicyclomine_toc.cfm
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-11 Labeling

Label is not available on this site.

02/29/2008 SUPPL-10 Labeling

Label is not available on this site.

09/07/2007 SUPPL-9 Labeling

Label is not available on this site.

08/08/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

10/21/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/26/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40230_Dicyclomine%20Hydrochloride_Prntlbl.pdf

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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