Details for New Drug Application (NDA): 206948

NDA 206948 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 206948

Tradename:	BENZONATATE
Applicant:	Puracap Pharm Llc
Ingredient:	benzonatate
Patents:	0

Pharmacology for NDA: 206948

Physiological Effect

Decreased Tracheobronchial Stretch Receptor Activity

Suppliers and Packaging for NDA: 206948

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZONATATE	benzonatate	CAPSULE;ORAL	206948	ANDA	Major Pharmaceuticals	0904-7153	0904-7153-61	100 BLISTER PACK in 1 CARTON (0904-7153-61) / 1 CAPSULE in 1 BLISTER PACK
BENZONATATE	benzonatate	CAPSULE;ORAL	206948	ANDA	QPharma Inc	42708-171	42708-171-21	21 CAPSULE in 1 BOTTLE, PLASTIC (42708-171-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 19, 2018	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Dec 19, 2018	TE:	AA	RLD:	No

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