Details for New Drug Application (NDA): 202765

NDA 202765 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-three 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-three suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for 202765

Tradename:	BENZONATATE
Applicant:	Cspc-nbp Pharm
Ingredient:	benzonatate
Patents:	0

Pharmacology for NDA: 202765

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 202765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	202765	ANDA	A-S Medication Solutions	50090-4968	50090-4968-0	15 CAPSULE in 1 BOTTLE (50090-4968-0)
BENZONATATE	benzonatate	CAPSULE;ORAL	202765	ANDA	A-S Medication Solutions	50090-4969	50090-4969-0	20 CAPSULE in 1 BOTTLE (50090-4969-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jul 31, 2015	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Aug 25, 2017	TE:	AA	RLD:	No

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