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

Pharmacology for NDA: 020189

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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 Inc.	0037-0430	0037-0430-01	100 TABLET in 1 BOTTLE, PLASTIC (0037-0430-01)
FELBATOL	felbamate	SUSPENSION;ORAL	020189	NDA	Meda Pharmaceuticals Inc.	0037-0431	0037-0431-01	100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 29, 1993	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jul 29, 1993	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	600MG/5ML
Approval Date:	Jul 29, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020189

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

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