LABETALOL HYDROCHLORIDE | N019425 | SEBELA IRELAND LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - Current (October 06, 2023) Orange Book Listing of RLD TRANDATE... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding TRANDATE (Labetalol Hydrochloride) Injection USP, 5 mg/mL, the reference listed drug under NDA #019425 held by Sebela Ireland LTD, seeking a determination on the suitability of the reference product for use in establishing bioequivalen | Suitability | 2023-10-17 | Open | Nines Consult Pharma |
Suitability Petition from Nines Consult Pharma, LLC FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Labetalol Hydrochloride Injection USP, 20 mg/4 mL (5 mg/mL) prefilled syringe suitable for submission in an abbreviated new drug applica | Suitability | 2023-10-17 | Open | Nines Consult Pharma |
Attachment 2 - US RLD Pack Insert of TRANDATE from Drugs@FDA (SUPPL-21 dated ... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding Trandate (labetalol hydrochloride), referencing the US reference listed drug pack insert from a November 2010 FDA supplement to support their petition for regulatory determination of suitability for ANDA purposes. | Suitability | 2023-10-17 | Open | Nines Consult Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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