Orange Book product · Generic (ANDA)
LEVALBUTEROL HYDROCHLORIDE
LEVALBUTEROL HYDROCHLORIDE
At a glance
Mar 20, 2009
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 20, 2009
17 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVALBUTEROL HYDROCHLORIDE
Strength
EQ 0.25% BASE
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
ANDA 078309
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of LEVALBUTEROL HYDROCHLORIDE
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- 2014LEVALBUTEROL HYDROCHLORIDEGeneric (ANDA)
ANDA 200875 · TEVA PARENTERAL
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ANDA 078171 · CIPLA
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ANDA 077800 · PHARMOBEDIENT
- 2008LEVALBUTEROL HYDROCHLORIDEGeneric (ANDA)
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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.
