Details for New Drug Application (NDA): 022462
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NDA 022462 describes GABLOFEN, which is a drug marketed by Piramal Critical and is included in one NDA. It is available from one supplier. Additional details are available on the GABLOFEN profile page.
The generic ingredient in GABLOFEN 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.
The generic ingredient in GABLOFEN 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 022462
| Tradename: | GABLOFEN |
| Applicant: | Piramal Critical |
| Ingredient: | baclofen |
| Patents: | 0 |
Pharmacology for NDA: 022462
| Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 022462
Suppliers and Packaging for NDA: 022462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GABLOFEN | baclofen | INJECTABLE;INTRATHECAL | 022462 | NDA | Piramal Critical Care Inc | 66794-151 | 66794-151-01 | 1 mL in 1 SYRINGE, GLASS (66794-151-01) |
| GABLOFEN | baclofen | INJECTABLE;INTRATHECAL | 022462 | NDA | Piramal Critical Care Inc | 66794-155 | 66794-155-01 | 20 mL in 1 SYRINGE, GLASS (66794-155-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 0.05MG/ML | ||||
| Approval Date: | Nov 19, 2010 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 0.5MG/ML | ||||
| Approval Date: | Nov 19, 2010 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 2MG/ML | ||||
| Approval Date: | Nov 19, 2010 | TE: | AP | RLD: | Yes | ||||
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