Details for New Drug Application (NDA): 214374
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The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Pharmacology for NDA: 214374
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 214374
Suppliers and Packaging for NDA: 214374
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 214374 | ANDA | Rising Pharma Holdings, Inc. | 16571-169 | 16571-169-01 | 100 TABLET in 1 BOTTLE (16571-169-01) |
BACLOFEN | baclofen | TABLET;ORAL | 214374 | ANDA | Rising Pharma Holdings, Inc. | 16571-171 | 16571-171-01 | 100 TABLET in 1 BOTTLE (16571-171-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 5, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 5, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Mar 5, 2021 | TE: | AB | RLD: | No |
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