Details for New Drug Application (NDA): 209102
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The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Pharmacology for NDA: 209102
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 209102
Suppliers and Packaging for NDA: 209102
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 209102 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8466 | 0615-8466-05 | 15 TABLET in 1 BLISTER PACK (0615-8466-05) |
BACLOFEN | baclofen | TABLET;ORAL | 209102 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8466 | 0615-8466-39 | 30 TABLET in 1 BLISTER PACK (0615-8466-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 28, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 28, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 28, 2017 | TE: | AB | RLD: | No |
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