Details for New Drug Application (NDA): 091133

NDA 091133 describes BENZONATATE, which is a drug marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Onesource Specialty, Puracap Pharm Llc, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in thirteen NDAs. It is available from forty-seven 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-seven suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for 091133

Tradename:	BENZONATATE
Applicant:	Onesource Specialty
Ingredient:	benzonatate
Patents:	0

Pharmacology for NDA: 091133

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 091133

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	091133	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8403	0615-8403-05	15 CAPSULE in 1 BLISTER PACK (0615-8403-05)
BENZONATATE	benzonatate	CAPSULE;ORAL	091133	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8403	0615-8403-21	21 CAPSULE in 1 BLISTER PACK (0615-8403-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 30, 2015	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jul 30, 2015	TE:	AA	RLD:	No

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