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-eight 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

Pharmacology for NDA: 022544

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jan 28, 2011	TE:	AB2	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 26, 2024	Product 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:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jan 28, 2011	TE:	AB2	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 26, 2024	Product 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:	RX	Dosage:	TABLET;ORAL			Strength	450MG
Approval Date:	Apr 18, 2023	TE:		RLD:	Yes

Expired US Patents for NDA 022544

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

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