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Drugs@FDA: FDA-Approved Drugs

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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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021113s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021113Orig1s018ltr.pdf
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
05/22/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021113s018lbl.pdf
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

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