Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040749
Company: THEPHARMANETWORK LLC

Products on ANDA 040749

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040749s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040749

BENZONATATE

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