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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022544


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NDA 022544 describes GRALISE, which is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. There is one patent 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-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 022544
Tradename:GRALISE
Applicant:Almatica
Ingredient:gabapentin
Patents:1
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 Almatica Pharma LLC 52427-803 52427-803-90 90 TABLET, FILM COATED in 1 BOTTLE (52427-803-90)
GRALISE gabapentin TABLET;ORAL 022544 NDA Almatica Pharma LLC 52427-804 52427-804-60 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 28, 2011TE:AB2RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 28, 2011TE:AB2RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength450MG
Approval Date:Apr 18, 2023TE:RLD:Yes

Expired US Patents for NDA 022544

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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