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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020189
Company: MYLAN SPECIALITY LP

Medication Guide

Healthcare Professional Sheet

Products on NDA 020189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FELBATOL	FELBAMATE	400MG	TABLET;ORAL	Prescription	AB	Yes	No
FELBATOL	FELBAMATE	600MG	TABLET;ORAL	Prescription	AB	Yes	Yes
FELBATOL	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2012	SUPPL-27	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020189Orig1s027ltr.pdf
07/06/2011	SUPPL-23	REMS-Proposal, Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020189s023ltr.pdf
04/23/2009	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020189s022ltr.pdf
06/26/2002	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/19/2002	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20189slr018ltr.pdf
08/28/1995	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1995	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1995	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/29/1994	SUPPL-9	Labeling		Label is not available on this site.
11/01/1994	SUPPL-8	Labeling		Label is not available on this site.
11/01/1994	SUPPL-6	Labeling		Label is not available on this site.
05/31/1994	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/02/1994	SUPPL-4	Labeling		Label is not available on this site.
12/21/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/20/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/17/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020189

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2012	SUPPL-27	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf
07/06/2011	SUPPL-23	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf
07/06/2011	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf
04/23/2009	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf

Therapeutic Equivalents for NDA 020189

FELBATOL

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	204595	ALVOGEN
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	201680	AMNEAL PHARMS
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	202284	ANI PHARMS
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	207093	TARO
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	208970	ZYDUS LIFESCIENCES
FELBATOL	FELBAMATE	400MG	TABLET;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	204595	ALVOGEN
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	201680	AMNEAL PHARMS
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	202284	ANI PHARMS
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	207093	TARO
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	208970	ZYDUS LIFESCIENCES
FELBATOL	FELBAMATE	600MG	TABLET;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP

SUSPENSION;ORAL; 600MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	202385	AMNEAL PHARMS
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	211333	NOVITIUM PHARMA
FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	206314	TARO
FELBATOL	FELBAMATE	600MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP

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