Last Updated: August 13, 2026

Generic Companies with Tentative Approvals for: Chartwell Rx

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Chartwell Rx Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Chartwell Rx	pramipexole dihydrochloride	202353	1.5MG	TABLET, EXTENDED RELEASE;ORAL
Chartwell Rx	hydrochlorothiazide; irbesartan	201524	12.5MG;150MG	TABLET;ORAL
Chartwell Rx	pramipexole dihydrochloride	202353	4.5MG	TABLET, EXTENDED RELEASE;ORAL
Chartwell Rx	pramipexole dihydrochloride	202353	0.375MG	TABLET, EXTENDED RELEASE;ORAL
Chartwell Rx	irbesartan; hydrochlorothiazide	201524	300MG; 25MG	TABLET; ORAL
Chartwell Rx	pramipexole dihydrochloride	202353	0.75MG	TABLET, EXTENDED RELEASE;ORAL
Chartwell Rx	pramipexole dihydrochloride	202353	3MG	TABLET, EXTENDED RELEASE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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