Orange Book product · Generic (ANDA)
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
At a glance
Sep 29, 2022
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 2022
3 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE
Strength
2.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 216859
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PHENYLEPHRINE HYDROCHLORIDE
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NDA 216830 · DR REDDYS LABS SA
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NDA 203826 · HIKMA
- 2019BIORPHENBrand (NDA)
NDA 212909 · DR REDDYS LABS SA
- 2015PHENYLEPHRINE HYDROCHLORIDEBrand (NDA)
NDA 207926 · ALCON
- 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
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ANDA 218129 · GLAND
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ANDA 215183 · CAPLIN
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ANDA 218110 · ASPIRO
- 2024PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218412 · HAINAN POLY
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.
