TAMSULOSIN HYDROCHLORIDE | N020579 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2026-P-3630 · 6 docket documents Rising Pharma Holdings, Inc. filed an amendment to suitability petition FDA-2026-P-3630 in response to an FDA information request, submitting the reference listed drug product labeling for FLOMAX and proposed labeling for Tamsulosin Hydrochloride Capsules, USP 0.8 mg as required by 21 CFR 314.93(d) | Suitability | 2026-04-28 | Open | Rising Pharma Holdings, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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