Orange Book product · Generic (ANDA)
PREGABALIN
PREGABALIN
At a glance
Mar 20, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 20, 2020
6 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 212865
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 219593 · UNICHEM
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ANDA 218529 · FOURRTS LABS
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ANDA 217857 · AIPING PHARM INC
- 2024PREGABALINGeneric (ANDA)
ANDA 205924 · MACLEODS PHARMS LTD
- 2024PREGABALINGeneric (ANDA)
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.
