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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020989
Company: COSETTE

Products on NDA 020989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVOXAC	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2000	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20989ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-989_Evoxac.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/08/2006	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020989s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020989s008ltr.pdf
12/13/2005	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020989s006ltr.pdf
01/04/2002	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/09/2001	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/31/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/19/2000	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Labels for NDA 020989

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2006	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020989s008lbl.pdf
12/13/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf
01/11/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf

Therapeutic Equivalents for NDA 020989

EVOXAC

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
EVOXAC	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AB	020989	COSETTE

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