Details for New Drug Application (NDA): 212378
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NDA 212378 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, and Zydus Lifesciences, and is included in forty-one NDAs. It is available from fifty-five 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-five 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-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 212378
| Tradename: | BACLOFEN |
| Applicant: | Andas 5 Holding |
| Ingredient: | baclofen |
| Patents: | 0 |
Pharmacology for NDA: 212378
| Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 212378
Suppliers and Packaging for NDA: 212378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | baclofen | TABLET;ORAL | 212378 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-780 | 10135-780-01 | 100 TABLET in 1 BOTTLE (10135-780-01) |
| BACLOFEN | baclofen | TABLET;ORAL | 212378 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-781 | 10135-781-01 | 100 TABLET in 1 BOTTLE (10135-781-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 9, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 9, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 30, 2021 | TE: | AB | RLD: | No | ||||
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