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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078520
Company: MYLAN LABS LTD

Other Important Information from FDA

Products on ANDA 078520

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	AP2	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	AP2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2008	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
05/13/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078520

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION; 30MG/10ML (3MG/ML)
TE Code = AP2

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	No	AP2	078156	DR REDDYS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP2	075841	HOSPIRA
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP2	078520	MYLAN LABS LTD

INJECTABLE;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP2

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	No	AP2	078156	DR REDDYS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP2	075841	HOSPIRA
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP2	078520	MYLAN LABS LTD

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