Orange Book product · Generic (ANDA)
PREGABALIN
PREGABALIN
At a glance
Feb 18, 2022
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
20MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 212604
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 217857 · AIPING PHARM INC
- 2024PREGABALINGeneric (ANDA)
ANDA 205924 · MACLEODS PHARMS LTD
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ANDA 214322 · CHANGZHOU PHARM
- 2024PREGABALINGeneric (ANDA)
ANDA 208113 · REGCON HOLDINGS
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.
