Details for New Drug Application (NDA): 214445
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NDA 214445 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Pharmobedient, Rubicon Research, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Hibrow Hlthcare, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Oxford Pharms, Ph Health, Regcon Holdings, Rising, Sun Pharm Inds Inc, Teva, Unichem, Usl Pharma, Watson Labs, Yiling, and Zydus Lifesciences, and is included in forty-two NDAs. It is available from fifty-seven 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 214445
| Tradename: | BACLOFEN |
| Applicant: | Rubicon Research |
| Ingredient: | baclofen |
| Patents: | 0 |
Pharmacology for NDA: 214445
| Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 214445
Suppliers and Packaging for NDA: 214445
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | baclofen | SOLUTION;ORAL | 214445 | ANDA | Advagen Pharma Ltd | 72888-103 | 72888-103-24 | 473 mL in 1 BOTTLE (72888-103-24) |
| BACLOFEN | baclofen | SOLUTION;ORAL | 214445 | ANDA | Advagen Pharma Ltd., | 72888-466 | 72888-466-01 | 473 mL in 1 BOTTLE (72888-466-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Dec 6, 2024 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jul 14, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
| Approval Date: | Jun 3, 2025 | TE: | AA | RLD: | No | ||||
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