Details for New Drug Application (NDA): 078401
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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.
Summary for 078401
Tradename: | BACLOFEN |
Applicant: | Northstar Hlthcare |
Ingredient: | baclofen |
Patents: | 0 |
Pharmacology for NDA: 078401
Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 078401
Suppliers and Packaging for NDA: 078401
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BACLOFEN | baclofen | TABLET;ORAL | 078401 | ANDA | Northstar RxLLC | 16714-072 | 16714-072-04 | 100 TABLET in 1 BOTTLE (16714-072-04) |
BACLOFEN | baclofen | TABLET;ORAL | 078401 | ANDA | Northstar RxLLC | 16714-072 | 16714-072-05 | 500 TABLET in 1 BOTTLE (16714-072-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 18, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 18, 2009 | TE: | AB | RLD: | No |
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