Details for New Drug Application (NDA): 215885
✉ Email this page to a colleague
The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 215885
Tradename: | BACLOFEN |
Applicant: | Mankind Pharma |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 215885
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 215885
Suppliers and Packaging for NDA: 215885
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 215885 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8518 | 0615-8518-05 | 15 TABLET in 1 BLISTER PACK (0615-8518-05) |
BACLOFEN | baclofen | TABLET;ORAL | 215885 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8518 | 0615-8518-39 | 30 TABLET in 1 BLISTER PACK (0615-8518-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription