Orange Book product · Generic (ANDA)
GABAPENTIN
GABAPENTIN
At a glance
Aug 07, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
GABAPENTIN
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 219319
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GABAPENTIN
- 2000NEURONTINBrand (NDA)
NDA 021129 · VIATRIS
- 1993NEURONTINBrand (NDA)
NDA 020235 · VIATRIS
- 2026GABAPENTINGeneric (ANDA)
ANDA 219814 · PRINSTON INC
- 2024GABAPENTINGeneric (ANDA)
ANDA 203643 · ABON PHARMS LLC
- 2024GABAPENTINGeneric (ANDA)
ANDA 218075 · ANNORA PHARMA
- 2024GABAPENTINGeneric (ANDA)
ANDA 216252 · EPIC PHARMA LLC
- 2024GABAPENTINGeneric (ANDA)
ANDA 217682 · ANNORA PHARMA
- 2023GABAPENTINGeneric (ANDA)
ANDA 208928 · IPCA LABS LTD
- 2023GABAPENTINGeneric (ANDA)
ANDA 217546 · LAURUS
- 2023GABAPENTINGeneric (ANDA)
ANDA 217116 · GRANULES
- 2023GABAPENTINGeneric (ANDA)
ANDA 216492 · RUBICON RESEARCH
- 2021GABAPENTINGeneric (ANDA)
ANDA 214957 · ASCENT PHARMS INC
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.
