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. 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. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
The generic ingredient in GRALISE is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two 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: | 0 |
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 | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 28, 2011 | TE: | AB2 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 450MG | ||||
| Approval Date: | Apr 18, 2023 | TE: | AB | 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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