Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204372
Company: INGENUS PHARMS LLC

Products on ANDA 204372

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204372

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204372Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204372

QUININE SULFATE

CAPSULE;ORAL; 324MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	203729	AMNEAL PHARMS
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	204372	INGENUS PHARMS LLC
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	203112	LUPIN
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	091661	TEVA PHARMS