Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076153
Company: TEVA PHARMS USA

• Other Important Information from FDA

Products on ANDA 076153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2002	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.AP.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2015	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/13/2012	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/22/2012	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/19/2009	SUPPL-8	Labeling		Label is not available on this site.