Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091661
Company: TEVA PHARMS

Products on ANDA 091661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/17/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/10/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/22/2013	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091661

QUININE SULFATE

CAPSULE;ORAL; 324MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUALAQUIN	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	Yes	AB	021799	SUN PHARM INDUSTRIES
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	203729	AMNEAL PHARMS
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	203112	LUPIN LTD
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	204372	NOVAST LABS
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	091661	TEVA PHARMS