Orange Book product · Brand (NDA)
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
At a glance
Jan 15, 2015
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 15, 2015
11 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE
Strength
2.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
NDA 207926
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 216830 · DR REDDYS LABS SA
- 2023IMMPHENTIVBrand (NDA)
NDA 203826 · HIKMA
- 2019BIORPHENBrand (NDA)
NDA 212909 · DR REDDYS LABS SA
- 2014VAZCULEPBrand (NDA)
NDA 204300 · EXELA PHARMA
- 2013PHENYLEPHRINE HYDROCHLORIDEBrand (NDA)
NDA 203510 · PARAGON BIOTECK
- 2026PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217032 · BAXTER HLTHCARE CORP
- 2025PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215617 · SOMERSET THERAPS LLC
- 2024PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218129 · GLAND
- 2024PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215183 · CAPLIN
- 2024PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218110 · ASPIRO
- 2024PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218412 · HAINAN POLY
- 2023PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217521 · BE PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
