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HYDROXYCHLOROQUINE SULFATE

ANDA

HYDROXYCHLOROQUINE SULFATE | A040274 | AUROBINDO PHARMA USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: PLAQUENIL(TE code: AB)

API Supply Chain16 active DMFs6 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

SCI PHARMTECH INCHYDROXYCHLOROQUINE SULFATE

DMF 86191990

IPCA LABORATORIES LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 140871999

ZYDUS LIFESCIENCES LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 149772000

EUROAPI HUNGARY LTDHYDROXYCHLOROQUINE SULFATE

DMF 206922007

ALKALOIDA CHEMICAL CO ZRTHYDROXYCHLOROQUINE SULFATE USP

DMF 235822010

CHONGQING KANGLE PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 308252016

LAURUS LABS LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 319562017

SRINI PHARMACEUTICALS PRIVATE LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 347652020

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE

DMF 348812020

ZHUHAI RUNDU PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE

DMF 349402022

DR REDDYS LABORATORIES LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 356162021

MSN LIFE SCIENCES PRIVATE LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 357592021

SMS PHARMACEUTICALS LTDHYDROXYCHLOROQUINE SULFATE USP

DMF 371312022

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDHYDROXYCHLOROQUINE SULFATE

DMF 374452022

SYMED LABS LTDHYDROXYCHLOROQUINE SULFATE

DMF 385342023

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE

DMF 392962023

SANOFI SYNTHELABO INCInactiveHYDROXYCHLOROQUINE SULFATE

DMF 46931982

SHANGHAI ZHONGXI PHARMACEUTICAL CO LTDInactiveHYDROXYCHLOROQUINE SULFATE

DMF 94901991

ALKALOIDA CHEMICAL CO LTDInactiveHYDROXYCHLOROQUINE SULFATE

DMF 127621997

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveHYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG

DMF 211152008

UNIMARK REMEDIES LTDInactiveHYDROXYCHLOROQUINE SULFATE USP

DMF 235932010

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveHYDROXYCHLOROQUINE SULFATE (USP)

DMF 257092012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2020	SUPPL -13	View Letter (PDF)
May 29, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 29, 1998

No patent or exclusivity listings for this strength.