Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084285
Company: LANNETT

Products on ANDA 084285

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084285

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.

Therapeutic Equivalents for ANDA 084285

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