Orange Book product · Brand (NDA)
LYRICA
PREGABALIN
At a glance
Jan 04, 2010
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 2010
16 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
20MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 022488
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017LYRICA CRBrand (NDA)
NDA 209501 · 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
- 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.
