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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078373
Company: SAGENT PHARMS INC

Products on ANDA 078373

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Prescription	AP1	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	AP1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2008	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
11/22/2019	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/15/2010	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/24/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078373

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP1	021113	HIKMA
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP1	078373	SAGENT PHARMS INC

INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP1	021113	HIKMA
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP1	078373	SAGENT PHARMS INC

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