An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021113
Company: HIKMA

Other Important Information from FDA

Products on NDA 021113

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	Yes	Yes
PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	AP1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021113

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2002	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21113ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2014	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021113Orig1s017ltr.pdf
10/18/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021113Orig1s012ltr.pdf
07/27/2009	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021113s008ltr.pdf
10/17/2008	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021113s006ltr.pdf
11/14/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021113s004ltr.pdf
09/29/2004	SUPPL-2	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21113s002ltr.pdf

Labels for NDA 021113

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021113s017lbl.pdf
10/18/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021113s012lbl.pdf
07/27/2009	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf
11/14/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021113s004lbl.pdf
03/04/2002	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-113_Pamidronate.htm

Therapeutic Equivalents for NDA 021113

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

Top