Details for New Drug Application (NDA): 091193
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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 091193
Tradename: | BACLOFEN |
Applicant: | Amneal |
Ingredient: | baclofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 091193
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 0.05MG/ML | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 0.5MG/ML | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 2MG/ML | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
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