HYDROCHLOROTHIAZIDE | A040702 | LEADING PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4956 Premier Consulting filed an amendment to an ANDA suitability petition (FDA-2024-P-4956) for hydrochlorothiazide oral liquid, clarifying in response to an FDA information request that the proposed dosage form is specifically a liquid rather than a solution, suspension, or powder for suspension, and c | Suitability | 2024-12-02 | Open | Premier Consulting |
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4956 Premier Consulting filed this amendment to its ANDA suitability petition (FDA-2024-P-4956) for Hydrochlorothiazide Oral Liquid, clarifying that the proposed dosage form will be a liquid administered orally, which the petitioner indicates may be formulated as a solution, suspension, or powder for sus | Suitability | 2024-11-13 | Open | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.