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Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine

… Contents FDA's Actions on OTC Oral Phenylephrine |  Key Information About Cough and Cold Nonprescription Drugs  |  Questions and Answers about Phenylephrine  |  Additional Information   Español FDA’s Actions on OTC Oral Phenylephrine FDA regulates over-the-counter (OTC), also …

FDA clarifies results of recent advisory committee meeting on oral phenylephrine

… Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter … committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data … support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, …

The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein

… advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant. Oral phenylephrine is an active ingredient found in several … this particular advisory committee meeting for the oral phenylephrine nasal decongestant? Dr. Michele: So, in 2007 …

FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review

… Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in … agency review of the available data determined that oral phenylephrine is not effective for this use. For now, … to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant. This is a proposed …

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

… announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This … Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level … reports of any adverse events associated with this issue. Phenylephrine Hydrochloride Injection, USP is an alpha-1 …

Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug

… user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being … 3/10/2024 2331231 3/24/2024 2331289 3/30/2024 F3360 Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% … 2331343 4/1/2024 2331349 4/23/2024 2331433 5/5/2024 F3352 Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% …

Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

… lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL … of adverse events or injuries associated with this recall. Phenylephrine hydrochloride Injection is used for the … Dec 2025 (NDC 81284-213-01) (See enclosed vial label). Phenylephrine hydrochloride Injection, USP, 10 mg/ mL, was …

Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

… PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in … black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. Risk Statement: Administration … Date  Distribution Dates  Region Distributed  71285-6092-1 Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in …

Phenylephrine/Ketorolac Written Request

… of the Federal Food, Drug, and Cosmetic Act for OMS302 (phenylephrine-ketorolac injection) 1%/0. (b) (4)%. We also … Plan (PSP). To obtain needed pediatric information on phenylephrine and ketorolac , the Food and Drug … you submit information from the study described below. μM phenylephrine/ (b) (4) μM ketorolac), and a …

Phenylephrine N203510 Clinical PREA

… 21, 2013 Martin P. Nevitt, M.D., M.P.H. February 20, 2013 Phenylephrine Hydrochloride Ophthalmic Solution, 2.5 % and … Clinical Review Martin P. Nevitt, M.D. M.P.H. NDA 203510 (phenylephrine ophthalmic solution) 0.25% and 10% Table of … Clinical Review Martin P. Nevitt, M.D. M.P.H. NDA 203510 (phenylephrine ophthalmic solution) 0.25% and 10% 7.2 Adequacy …

Phenylephrine N203510 Statistical PREA

… NDA/BLA #: NDA 203510 Supplement #: 0000 Drug Name: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% … 2.1.1 Phenylephrine … 2: Effects on pupil dilation of four concentrations of phenylephrine based on Chawdhary (1984) … 6 Table 3: Change in pupil size after tropicamide and phenylephrine based Yospaiboon (2004) …

Phenylephrine N203510 Clinpharm PREA

… Date(s): September 21, 2012 PUDFA: March 21, 2013 Drug Phenylephrine hydrochloride Product/Formulation; Strength(s) Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% … Submission Type 505(b)(2) ; Priority BACKGROUND Phenylephrine is an alpha-adrenergic receptor sympathetic …

215352 tropicamide-phenylephrine Statistical prea

… STUDIES BLA/Serial #: 215352 MydCombi (Tropicamide 1%/ Phenylephrine HCl 2.5%) Ophthalmic Spray Drug Name: … MydCombi is a fixed-dose combination of tropicamide 1% - phenylephrine 2.5% ophthalmic solution (hereafter referred to … minutes). Of note, the individual components of MydCombi, phenylephrine 2.5% (hereafter referred to as PH) and …

Phenylephrine hydrochloride Non-Compliance Letter

… of the Federal Food, Drug, and Cosmetic Act (the Act) for phenylephrine hydrochloride injection, which was approved on … A ROCA 05/31/2023 12:38:11 PM Reference ID: 5182004 … Phenylephrine hydrochloride Non-Compliance Letter …

215352 tropicamide-phenylephrine CDTL DD prea

… Lloyd, MD, Wiley Chambers, MD MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% MEDICAL … DARRTS stamp date Established/Proper Name tropicamide and phenylephrine hydrochloride ophthalmic spray, 1%/2.5% … Lloyd, MD, Wiley Chambers, MD MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% …

214_205388S6 phenylephrine and ketorolac clinical bpca

… Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 2 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 3 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 5 …

214_205388s6 phenylephrine and ketorolac clinical bpca

… Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 2 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 3 … Review William M. Boyd, MD NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% 5 …

215_205388S6 phenylephrine and ketorolac statistical bpca

… #: Supplement #: NDA 205388 006 Drug Name: Omidria™ (Phenylephrine HCL/Ketoroloc Tromethamine) Indication(s): … NDA supplement was a pediatric use supplement. Omidria® (phenylephrine and ketorolac 1% / 0.3% (also refer to as … Study 007 was a randomized, parallel-group, double-masked, phenylephrine(PE)-controlled study of OMS302 in young …

215_205388s6 phenylephrine and ketorolac statistical bpca

… #: Supplement #: NDA 205388 006 Drug Name: Omidria™ (Phenylephrine HCL/Ketoroloc Tromethamine) Indication(s): … NDA supplement was a pediatric use supplement. Omidria® (phenylephrine and ketorolac 1% / 0.3% (also refer to as … Study 007 was a randomized, parallel-group, double-masked, phenylephrine(PE)-controlled study of OMS302 in young …

213_205388S6 phenylephrine and ketorolac CDTL clinical bpca

… Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … OMS302) is a fixed-dose combination product containing phenylephrine hydrochloride (PE), an α1-adrenergic receptor …

213_205388s6 phenylephrine and ketorolac cdtl clinical bpca

… Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … Boyd, MD, Wiley Chambers, M.D. NDA 205388/S-006 OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% … OMS302) is a fixed-dose combination product containing phenylephrine hydrochloride (PE), an α1-adrenergic receptor …

N203826-000 phenylephrine NC ltr (6-8-17)

… of the Federal Food, Drug, and Cosmetic Act (the Act) for phenylephrine hydrochloride injection, USP, 10 mg/mL, which … H HERTZ 06/08/2017 Reference ID: 4109102 ( … N203826-000 phenylephrine NC ltr (6-8-17) …

Podcast for Q&A Phenylephrine, March 14, 2024

… track. 44.1k, 16 bit, Stereo Master.� … Podcast for Q&A Phenylephrine, March 14, 2024 …

N203826-000 phenylephrine PREA Response (7-21-17)

… … N203826-000 phenylephrine PREA Response (7-21-17) …

Unapproved Prescription Cough, Cold, and Allergy Products

… A TAN 12X SUSPENSION PYRILAMINE TANNATE 30 MG 65162 0530 PHENYLEPHRINE TANNATE 5 MG ACCUHIST DM GUAIFENESIN 50 MG … MALEATE 8 MG 066440 2376 METHSCOPOLAMINE NITRATE 2.5 MG PHENYLEPHRINE HYDROCHLORIDE 20 MG AH CHEW SUSPENSION CHLORPHENIRAMINE TANNATE 35 MG 59196 0015 PHENYLEPHRINE TANNATE 25 MG AH CHEW ULTRA CHEWABLE TABLET …