Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020189
Company: MYLAN SPECIALITY LP
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
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 Labeling, REMS-Proposal 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.

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 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf
07/06/2011 SUPPL-23 REMS-Proposal 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

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 INC
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 208970 CADILA
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 207093 TARO
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 INC
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 208970 CADILA
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 207093 TARO
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 206314 TARO
FELBAMATE FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription No AB 211333 VISTAPHARM
FELBATOL FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription Yes AB 020189 MYLAN SPECIALITY LP

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