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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040230
Company: LANNETT

Products on ANDA 040230

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040230

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.

Labels for ANDA 040230

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

Therapeutic Equivalents for ANDA 040230

DICYCLOMINE HYDROCHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	040317	AUROBINDO PHARMA USA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	217916	BIONPHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	216760	COREPHARMA
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	216736	RUBICON
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	216782	TWI PHARMS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	085223	WATSON LABS

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