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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209093
Company: AMNEAL PHARMS

Products on ANDA 209093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209093

OSELTAMIVIR PHOSPHATE

CAPSULE;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	211823	ALEMBIC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	209093	AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	215208	EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	209438	HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	217467	INVAGEN PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	208348	LUPIN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	207211	MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	212544	MSN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	202595	NATCO
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	209421	STRIDES PHARMA
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	212739	SUNSHINE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	No	AB	208578	ZYDUS PHARMS
TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 30MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021087	ROCHE

CAPSULE;ORAL; EQ 45MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	211823	ALEMBIC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	209093	AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	215208	EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	209438	HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	217467	INVAGEN PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	208348	LUPIN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	207211	MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	212544	MSN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	202595	NATCO
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	209421	STRIDES PHARMA
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	212739	SUNSHINE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	No	AB	208578	ZYDUS PHARMS
TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 45MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021087	ROCHE

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	211823	ALEMBIC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209093	AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	215208	EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	218009	HAINAN POLY
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209438	HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	217467	INVAGEN PHARMS
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208348	LUPIN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	207211	MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	212544	MSN
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	202595	NATCO
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209421	STRIDES PHARMA
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	212739	SUNSHINE
OSELTAMIVIR PHOSPHATE	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	208578	ZYDUS PHARMS
TAMIFLU	OSELTAMIVIR PHOSPHATE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021087	ROCHE

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