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): 090520
Company: HIKMA

Products on ANDA 090520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE/75ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2013	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
08/19/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/23/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090520

ALENDRONATE SODIUM

SOLUTION;ORAL; EQ 70MG BASE/75ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE/75ML	SOLUTION;ORAL	Prescription	No	AA	090520	HIKMA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE/75ML	SOLUTION;ORAL	Prescription	No	AA	214512	NOVITIUM PHARMA

Top