Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077433
Company: AREVA PHARMS

Products on ANDA 077433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	60MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2008	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
11/29/2016	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/29/2016	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077433

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION; 30MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	077433	AREVA PHARMS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075290	HIKMA

INJECTABLE;INJECTION; 90MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	077433	AREVA PHARMS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075290	HIKMA