GABAPENTIN | A075428 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Rising Pharma Holdings, Inc. FDA-2026-P-5123 Rising Pharma Holdings, Inc. filed this amendment to suitability petition FDA-2026-P-5123, received on May 7, 2026, seeking permission to file an ANDA for Gabapentin Capsules, 150 mg. In response to an FDA information request dated May 28, 2026, Rising Pharma submitted the proposed product labeling | Suitability | 2026-06-05 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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