Details for New Drug Application (NDA): 215422
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NDA 215422 describes LYVISPAH, which is a drug marketed by Amneal and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the LYVISPAH profile page.
The generic ingredient in LYVISPAH 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 LYVISPAH 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.
Pharmacology for NDA: 215422
| Mechanism of Action | GABA A Agonists GABA B Agonists |
Medical Subject Heading (MeSH) Categories for 215422
Suppliers and Packaging for NDA: 215422
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYVISPAH | baclofen | GRANULES;ORAL | 215422 | NDA | Amneal Pharmaceuticals LLC | 64896-076 | 64896-076-09 | 90 PACKET in 1 CARTON (64896-076-09) / 1 GRANULE in 1 PACKET |
| LYVISPAH | baclofen | GRANULES;ORAL | 215422 | NDA | Amneal Pharmaceuticals LLC | 64896-077 | 64896-077-09 | 90 PACKET in 1 CARTON (64896-077-09) / 1 GRANULE in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULES;ORAL | Strength | 5MG/PACKET | ||||
| Approval Date: | Nov 22, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 29, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TREATING SPASTICITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 29, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 29, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES | ||||||||
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