Details for New Drug Application (NDA): 217687
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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.
Summary for 217687
Tradename: | BACLOFEN |
Applicant: | Micro Labs |
Ingredient: | baclofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217687
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 217687
Suppliers and Packaging for NDA: 217687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 217687 | ANDA | Micro Labs Limited | 42571-427 | 42571-427-01 | 100 TABLET in 1 BOTTLE (42571-427-01) |
BACLOFEN | baclofen | TABLET;ORAL | 217687 | ANDA | Micro Labs Limited | 42571-428 | 42571-428-01 | 100 TABLET in 1 BOTTLE (42571-428-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 8, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 8, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 8, 2023 | TE: | AB | RLD: | No |
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