Orange Book product · Generic (ANDA)
PREGABALIN
PREGABALIN
At a glance
Sep 20, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 2019
6 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 091228
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREGABALIN
- 2017LYRICA CRBrand (NDA)
NDA 209501 · UPJOHN
- 2010LYRICABrand (NDA)
NDA 022488 · UPJOHN
- 2004LYRICABrand (NDA)
NDA 021446 · UPJOHN
- 2026PREGABALINGeneric (ANDA)
ANDA 219593 · UNICHEM
- 2026PREGABALINGeneric (ANDA)
ANDA 218529 · FOURRTS LABS
- 2025PREGABALINGeneric (ANDA)
ANDA 209530 · JUBILANT GENERICS
- 2025PREGABALINGeneric (ANDA)
ANDA 091222 · PHARMOBEDIENT
- 2025PREGABALINGeneric (ANDA)
ANDA 206942 · TORRENT
- 2025PREGABALINGeneric (ANDA)
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.
