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 four 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-four 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-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 215422
| Tradename: | LYVISPAH |
| Applicant: | Amneal |
| Ingredient: | baclofen |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Jul 29, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TREATING SPASTICITY | ||||||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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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