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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075290
Company: HIKMA

Other Important Information from FDA

Products on ANDA 075290

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	90MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075290

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate%20Disodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75290ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2012	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/17/2012	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/09/2009	SUPPL-14	Labeling		Label is not available on this site.
07/24/2008	SUPPL-11	Labeling		Label is not available on this site.
09/23/2007	SUPPL-10	Labeling		Label is not available on this site.
07/19/2005	SUPPL-8	Labeling		Label is not available on this site.
05/11/2005	SUPPL-6	Labeling		Label is not available on this site.
05/18/2004	SUPPL-4	Labeling		Label is not available on this site.
11/07/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075290

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-290_Pamidronate%20Disodium_prntlbl.pdf

Therapeutic Equivalents for ANDA 075290

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

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