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): 201270
Company: LARKEN LABS INC

Products on ANDA 201270

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201270

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2017	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 201270

DEXAMETHASONE

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	No	AB	217695	APOTEX
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	Yes	AB	084610	HIKMA
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	No	AB	201270	LARKEN LABS INC
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	No	AB	215604	NOVITIUM PHARMA
DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET;ORAL	Prescription	No	AB	216282	ZYDUS LIFESCIENCES

Top