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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202595
Company: NATCO

Products on ANDA 202595

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 202595

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2016	ORIG-1	Approval			Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202595Orig1s000lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2021	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/09/2021	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/09/2021	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 202595

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202595Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202595

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	218565	LAURUS
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	218565	LAURUS
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	218565	LAURUS
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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