Orange Book product · Generic (ANDA)
APIXABAN
APIXABAN
At a glance
Dec 23, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2019
6 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
APIXABAN
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 210013
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of APIXABAN
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ANDA 210066 · HETERO LABS LTD V
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ANDA 210026 · AUROBINDO PHARMA LTD
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ANDA 210185 · ZYDUS PHARMS
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ANDA 209845 · BRECKENRIDGE
- 2020APIXABANGeneric (ANDA)
ANDA 209898 · REGCON HOLDINGS
- 2020APIXABANGeneric (ANDA)
ANDA 210180 · ACCORD HLTHCARE
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.
