Details for New Drug Application (NDA): 020189
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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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | TABLET;ORAL | 020189-002 | 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 | 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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