Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203775
Company: RISING

Products on ANDA 203775

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203775

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2014	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
07/24/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203775

CEVIMELINE HYDROCHLORIDE

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	215056	AUROBINDO PHARMA
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	218290	BIONPHARMA
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	091591	HIKMA
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	206808	MACLEODS PHARMS LTD
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	204746	NOVEL LABS INC
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	203775	RISING
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	216682	RUBICON RESEARCH
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	220267	ZYDUS LIFESCIENCES
EVOXAC	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AB	020989	COSETTE