Orange Book product · Generic (ANDA)
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
NOREPINEPHRINE BITARTRATE
At a glance
Aug 11, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
NOREPINEPHRINE BITARTRATE
Strength
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 219692
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NOREPINEPHRINE BITARTRATE
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ANDA 216272 · NEPHRON
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ANDA 220483 · SAGENT
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ANDA 218595 · MSN
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ANDA 219924 · ANTHEA PHARMA
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ANDA 219443 · BIOCON PHARMA
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ANDA 218758 · RISING
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ANDA 217575 · CAPLIN
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.
