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Details for New Drug Application (NDA): 022544

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NDA 022544 describes GRALISE, which is a drug marketed by Depomed Inc and is included in one NDA. It is available from three suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GRALISE profile page.

The generic ingredient in GRALISE is gabapentin. There are twenty-six drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 022544

Tradename:
GRALISE
Applicant:
Depomed Inc
Ingredient:
gabapentin
Patents:9
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 022544

Suppliers and Packaging for NDA: 022544

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRALISE
gabapentin
TABLET;ORAL 022544 NDA Depomed, Inc. 13913-004 13913-004-19 90 TABLET, FILM COATED in 1 BOTTLE (13913-004-19)
GRALISE
gabapentin
TABLET;ORAL 022544 NDA Depomed, Inc. 13913-005 13913-005-19 90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 28, 2011TE:BXRLD:Yes
Patent:6,340,475Patent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,488,962Patent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,635,280Patent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022544

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 20116,340,475► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 20116,340,475► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 20116,635,280► subscribe
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