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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214512
Company: NOVITIUM PHARMA

Products on ANDA 214512

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2026	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214512

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

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