Orange Book product · Generic (ANDA)
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
At a glance
Dec 18, 2024
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE
Strength
2.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 218129
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PHENYLEPHRINE HYDROCHLORIDE
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NDA 203826 · HIKMA
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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
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ANDA 217032 · BAXTER HLTHCARE CORP
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ANDA 215617 · SOMERSET THERAPS LLC
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ANDA 215183 · CAPLIN
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ANDA 218110 · ASPIRO
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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.
