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): 201209
Company: THEPHARMANETWORK LLC

Products on ANDA 201209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZONATATE	BENZONATATE	150MG	CAPSULE;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 201209

BENZONATATE

CAPSULE;ORAL; 150MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZONATATE	BENZONATATE	150MG	CAPSULE;ORAL	Prescription	No	AA	211518	ASCENT PHARMS INC
BENZONATATE	BENZONATATE	150MG	CAPSULE;ORAL	Prescription	No	AA	040627	THEPHARMANETWORK LLC
BENZONATATE	BENZONATATE	150MG	CAPSULE;ORAL	Prescription	No	AA	201209	THEPHARMANETWORK LLC

Top