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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216859

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
2.5%
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 2.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A216859
Product Number: 001
Approval Date: Sep 29, 2022
Applicant Holder Full Name: MANKIND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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