← FDA DRUG APPROVALS

FDA ANDA · ANDA204372

QUININE SULFATE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA204372
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-22
LATEST ACTION
2019-12-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

QUININE SULFATEPrescription
QUININE SULFATE 324MG · CAPSULE · ORAL

Approval history

2019-12-11Labeling · Supplement 1 · standardAP
2015-07-22UNKNOWN · OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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