Details for New Drug Application (NDA): 022544
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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 |
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
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 | 022544-001 | Jan 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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