Orange Book product · Generic (ANDA)
PREGABALIN
PREGABALIN
At a glance
Jan 28, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
330MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 217857
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREGABALIN
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ANDA 205924 · MACLEODS PHARMS LTD
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ANDA 214322 · CHANGZHOU PHARM
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ANDA 208113 · REGCON HOLDINGS
- 2024PREGABALINGeneric (ANDA)
ANDA 209883 · STRIDES PHARMA
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.
