An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040682
Company: HERITAGE PHARMS LABS

Products on ANDA 040682

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 040682

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/01/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/06/2010	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040682

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

Top