Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211330
Company: PAI HOLDINGS PHARM

Products on ANDA 211330

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 211330

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2025	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
06/25/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/25/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211330

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