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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210562

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NDA 210562 describes BENZONATATE, which is a drug marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in thirteen NDAs. It is available from forty-four suppliers. Additional details are available on the BENZONATATE profile page.

The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for 210562

Tradename:	BENZONATATE
Applicant:	Chartwell Rx
Ingredient:	benzonatate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Nov 9, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Nov 9, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Nov 9, 2018	TE:		RLD:	No

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