Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210186
Company: AMNEAL PHARMS NY

Products on ANDA 210186

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2018	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
08/07/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/07/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/07/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/07/2021	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210186

OSELTAMIVIR PHOSPHATE

FOR SUSPENSION;ORAL; EQ 6MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212784	AJANTA PHARMA LTD
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	208823	ALVOGEN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210186	AMNEAL PHARMS NY
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212858	APTAPHARMA INC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215538	EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	209590	HETERO LABS LTD V
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	208347	LUPIN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215313	MSN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211894	STRIDES PHARMA
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213594	SUNSHINE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211125	TEVA PHARMS USA
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	209113	ZYDUS PHARMS
TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 6MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	021246	ROCHE