LABETALOL HYDROCHLORIDE | N018716 | ALVOGEN INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 | Denied | Nines Consult Pharma, LLC |
Attachment 3 - Proposed generic Pack Insert of Labetalol Hydrochloride Inject... FDA-2023-P-4552 Nines Consult Pharma, LLC filed a suitability petition regarding a proposed generic pack insert for labetalol hydrochloride injection, likely seeking FDA confirmation that the generic formulation meets bioequivalence and manufacturing standards for approval as an ANDA. | Suitability | 2023-10-17 | Denied | Nines Consult Pharma, LLC |
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2022-P-2768 Macleods Pharmaceuticals Limited submitted this citizen petition on November 4, 2022, requesting that the FDA determine whether the reference listed drug Trandate (Labetalol hydrochloride) tablets, 100 mg strength, listed under NDA N018716, was withdrawn from commercial distribution for reasons othe | Other | 2022-11-04 | Denied | Macleods Pharmaceuticals Limited |
J R Rapoza Associates, Inc. - Citizen Petition FDA-2010-P-0326 JR Rapoza Associates, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA Commissioner determine whether Labetalol Hydrochloride oral tablets, 300mg (Trandate, NDA N018716, Prometheus Labs) was withdrawn from commercial distribution for reasons other than safety | 505(q) | 2010-06-30 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.