GABA - Generic Drug Details
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Generic filers with tentative approvals for GABA
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 600MG | TABLET; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 300MG | TABLET; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 600MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for GABA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-005 | Apr 18, 2023 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Watson Labs | GABAPENTIN | gabapentin | CAPSULE;ORAL | 075485-002 | May 11, 2007 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Teva Pharms | GABAPENTIN | gabapentin | CAPSULE;ORAL | 075435-002 | Oct 8, 2004 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-003 | Apr 18, 2023 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
