Details for New Drug Application (NDA): 091193
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NDA 091193 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Norvium Bioscience, Rubicon, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Graviti Pharms, Hibrow Hlthcare, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, and Zydus Lifesciences, and is included in forty-two NDAs. It is available from fifty-four suppliers. Additional details are available on the BACLOFEN profile page.
The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the baclofen profile page.
The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the baclofen profile page.
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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