Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216492
Company: RUBICON RESEARCH

Products on ANDA 216492

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216492

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216492

GABAPENTIN

SOLUTION;ORAL; 250MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	076403	ACELLA PHARMS LLC
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091286	AJENAT PHARMS
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	202024	AMNEAL PHARMS
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	217682	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	078974	MISSION PHARMACAL
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211330	PAI HOLDINGS PHARM
GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216492	RUBICON RESEARCH
NEURONTIN	GABAPENTIN	250MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	021129	VIATRIS