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CHLOROQUINE PHOSPHATE

ANDA

CHLOROQUINE PHOSPHATE | A083082 | HIKMA PHARMACEUTICALS

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Suven Life Sciences Limited FDA-2018-P-3616 · 11 docket documents Suven Life Sciences Limited filed this citizen petition on September 21, 2018, requesting that the FDA designate Chloroquine Phosphate Tablets 250 mg (eq 150 mg base) held by Natco Pharma Limited (ANDA 091621) as a reference standard for developmental studies supporting their own ANDA application, b	Other	2018-09-25	Granted	Suven Life Sciences Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs1 inactive

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

IPCA LABORATORIES LTDCHLOROQUINE PHOSPHATE USP

DMF 92351991

NATCO PHARMA LTDCHLOROQUINE PHOSPHATE

DMF 330672019

COHANCE LIFESCIENCES LTDCHLOROQUINE PHOSPHATE USP

DMF 341302019

ICN HUNGARY CO LTDInactiveCHLOROQUINE PHOSPHATE

DMF 104721993

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

Products (2)

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#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 17, 1999