Orange Book product · Brand (NDA)
LYRICA
PREGABALIN
At a glance
Dec 30, 2004
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 2004
21 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 021446
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 2010LYRICABrand (NDA)
NDA 022488 · 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.
