Details for New Drug Application (NDA): 040682

NDA 040682 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 040682

Tradename:	BENZONATATE
Applicant:	Heritage Pharms Labs
Ingredient:	benzonatate
Patents:	0

Pharmacology for NDA: 040682

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 040682

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	040682	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-898	23155-898-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-898-01)
BENZONATATE	benzonatate	CAPSULE;ORAL	040682	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-898	23155-898-05	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-898-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 30, 2007	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jul 30, 2007	TE:	AA	RLD:	No

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