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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 020189

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NDA 020189 describes FELBATOL, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the FELBATOL profile page.

The generic ingredient in FELBATOL is felbamate. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 020189
Tradename:FELBATOL
Applicant:Mylan Speciality Lp
Ingredient:felbamate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020189
Suppliers and Packaging for NDA: 020189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBATOL felbamate SUSPENSION;ORAL 020189 NDA Meda Pharmaceuticals 0037-0430 0037-0430-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-0430-01)
FELBATOL felbamate SUSPENSION;ORAL 020189 NDA Meda Pharmaceuticals 0037-0431 0037-0431-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jul 29, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jul 29, 1993TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength600MG/5ML
Approval Date:Jul 29, 1993TE:ABRLD:Yes

Expired US Patents for NDA 020189

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993   Start Trial   Start Trial
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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