Details for New Drug Application (NDA): 091310

NDA 091310 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 091310

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

Pharmacology for NDA: 091310

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 091310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	091310	ANDA	Proficient Rx LP	71205-659	71205-659-10	10 CAPSULE in 1 BOTTLE (71205-659-10)
BENZONATATE	benzonatate	CAPSULE;ORAL	091310	ANDA	Proficient Rx LP	71205-659	71205-659-14	14 CAPSULE in 1 BOTTLE (71205-659-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 16, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jan 16, 2015	TE:	AA	RLD:	No

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