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QUESTRAN

ANDA

CHOLESTYRAMINE | A073403 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Bristol-Myers FDA-1987-P-0130 · 5 docket documents Bristol-Myers filed this citizen petition in September 1987 requesting that the FDA determine an Abbreviated New Drug Application is suitable for a cholestyramine tablet containing 1.0 g per tablet, which would provide a more convenient alternative to the existing Questran Powder formulation while m	Other	2017-05-16	Granted	Bristol-Myers

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

API Supply Chain3 active DMFs2 inactive

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

PUROLITE LLCCHOLESTYRAMINE RESIN USP

DMF 73241988

ION EXCHANGE INDIA LTDCHOLESTYRAMINE RESIN USP (INDION 454)

DMF 231712009

PHAEX POLYMERS PRIVATE LTDCHOLESTYRAMINE RESIN USP AS IN

DMF 276072013

DOW CHEMICAL COInactiveCHOLESTYRAMINE USP

DMF 57591985

ROHM AND HAAS COInactiveCHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-276

DMF 65061986

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

Products (2)

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#001 — EQ 1GM RESIN

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 28, 1994

No patent or exclusivity listings for this strength.

#002 — EQ 800MG RESIN

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 27, 1999