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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040319
Company: AUROBINDO PHARMA USA

Products on ANDA 040319

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/07/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40319ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/28/2012	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
11/30/2007	SUPPL-3	Labeling		Label is not available on this site.
12/12/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040319

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	218018	ANNORA PHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	040319	AUROBINDO PHARMA USA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	216639	COREPHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	084285	LANNETT
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	217531	PRINSTON INC
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	219242	RISING
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	217054	TWI PHARMS
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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