Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203510

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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: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N203510
Product Number: 001
Approval Date: Mar 21, 2013
Applicant Holder Full Name: PARAGON BIOTECK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
10%
Marketing Status: Prescription

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: PHENYLEPHRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 10%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N203510
Product Number: 002
Approval Date: Mar 21, 2013
Applicant Holder Full Name: PARAGON BIOTECK INC
Marketing Status:  Prescription
Patent and Exclusivity Information