Orange Book product · Generic (ANDA)
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
At a glance
Apr 08, 2021
Approved
Generic (ANDA)
Application
AP1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2021
5 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE
Strength
10MG/ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP1
Application
ANDA 211920
Product number
003
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 207926 · ALCON
- 2014VAZCULEPBrand (NDA)
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NDA 203510 · PARAGON BIOTECK
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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.
