PHENYLEPHRINE HYDROCHLORIDE | N203826 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Apotex Corp. FDA-2026-P-6257 · 7 docket documents Apotex Corp. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA find Phenylephrine Hydrochloride Injection, 1 mg/10 mL (0.1 mg/mL) in a pre-filled syringe suitable for submission as an Abbreviated New Drug Application (ANDA). The p | Suitability | 2026-06-02 | Open | Apotex Corp. |
Suitability Petition from VPCI, Inc. FDA-2018-P-1008 · 5 docket documents VPCI, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Food, Drug and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for phenylephrine hydrochloride injection at a concentration of 0.1 mg/mL, which differs from the Reference Listed Drug VAZCULEP ( | Suitability | 2018-03-07 | Withdrawn | VPCI, Inc. |
Citizen Petition from the University of Florida FDA-2015-P-4131 · 6 docket documents The University of Florida filed this citizen petition under 21 CFR Part 10.30 requesting that the FDA issue a final rule removing oral phenylephrine (both phenylephrine hydrochloride and phenylephrine bitartrate) from the Final Monograph for OTC nasal decongestant drug products, arguing that subsequ | Other | 2015-11-13 | Partially Denied | the University of Florida |
Citizen Petition From Sheppard, Mullen, Richter, & Hampton LLP FDA-2014-P-0311 · 3 docket documents Sheppard, Mullin, Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) requesting that the FDA declare Phenylephrine Hydrochloride Injection, USP, 10 mg/mL in a 5 mL glass vial suitable for submission in an ANDA, with the reference listed drug being West-Ward Pharmac | Other | 2014-03-28 | Open | Sheppard, Mullen, Richter, & Hampton LLP |
Citizen Petition from Strides Inc. FDA-2006-P-0395 · 7 docket documents Strides Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Ibuprofen Potassium 200 mg Phenylephrine Hydrochloride 10 mg Capsules, which substitutes phenylephrine hydrochloride | Other | 2008-11-24 | Withdrawn | Strides Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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