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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091310
Company: ACELLA

Products on ANDA 091310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	AA	No	No
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091310

BENZONATATE

CAPSULE;ORAL; 100MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	091310	ACELLA
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	211518	ASCENT PHARMS INC
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	081297	BIONPHARMA
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	202765	CSPC-NBP PHARM
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	040682	HERITAGE PHARMS LABS
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	206948	PURACAP PHARM LLC
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	091133	STRIDES PHARMA
BENZONATATE	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	No	AA	040597	ZYDUS PHARMS USA
TESSALON	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	Yes	AA	011210	PFIZER

CAPSULE;ORAL; 200MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	091310	ACELLA
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	211518	ASCENT PHARMS INC
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	081297	BIONPHARMA
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	202765	CSPC-NBP PHARM
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	040682	HERITAGE PHARMS LABS
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	206948	PURACAP PHARM LLC
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	091133	STRIDES PHARMA
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	040749	THEPHARMANETWORK LLC
BENZONATATE	BENZONATATE	200MG	CAPSULE;ORAL	Prescription	No	AA	040597	ZYDUS PHARMS USA

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