Orange Book product · Brand (NDA)

PHENYLEPHRINE HYDROCHLORIDE

Brand (NDA)NDA 203510TE ATRX PARAGON BIOTECK

Mar 21, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 21, 2013
13 yr 5 mo ago
Today
Patent 8859623 expires
Listed method-of-use patent (U-1594) expiration.
Nov 14, 2033
in 7 yr 6 mo

Active ingredient

PHENYLEPHRINE HYDROCHLORIDE

Strength

2.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Application

NDA 203510

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8859623	Nov 14, 2033	in 7 yr 6 mo	U-1594