Orange Book product · Brand (NDA)
NEURONTIN
GABAPENTIN
At a glance
Oct 09, 1998
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 1998
28 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
GABAPENTIN
Strength
600MG
Dosage form
TABLET
Route
ORAL
TE code
AB1
Application
NDA 020882
Product number
001
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.
- 2000NEURONTINBrand (NDA)
NDA 021129 · VIATRIS
- 1993NEURONTINBrand (NDA)
NDA 020235 · VIATRIS
- 2026GABAPENTINGeneric (ANDA)
ANDA 219814 · PRINSTON INC
- 2025GABAPENTINGeneric (ANDA)
ANDA 219319 · SENORES PHARMS
- 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 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.
