Details for New Drug Application (NDA): 081297

NDA 081297 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 081297

Tradename:	BENZONATATE
Applicant:	Bionpharma
Ingredient:	benzonatate
Patents:	0

Pharmacology for NDA: 081297

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 081297

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	081297	ANDA	RPK Pharmaceuticals, Inc.	53002-0411	53002-0411-1	10 CAPSULE in 1 BOTTLE (53002-0411-1)
BENZONATATE	benzonatate	CAPSULE;ORAL	081297	ANDA	RPK Pharmaceuticals, Inc.	53002-0411	53002-0411-2	15 CAPSULE in 1 BOTTLE (53002-0411-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 29, 1993	TE:	AA	RLD:	No

Profile for product number 002

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

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