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QUININE SULFATE

ANDA

QUININE SULFATE | A204372 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF4 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHIVA INTERNATIONALQUININE SULFATE USP

DMF 240632010

DSM MINERA BVInactiveQUININE SULFATE USP XIX/ NF XII

DMF 33981978

BOEHRINGER MANNHEIM GMBHInactiveQUININE SULFATE

DMF 94621991

PT SINKONA INDONESIA LESTARIInactiveQUININE SULFATE USP

DMF 199052006

PT KIMIA FARMA PERSERO TBKInactiveQUININE SULFATE

DMF 209512007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 24, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 324MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 22, 2015

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC became the applicant for quinine sulfate (NDA 204372) following a change from NOVAST LABS.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for quinine sulfate (QUININE SULFATE, NDA 204372) changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC