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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203231
Company: INFORLIFE

Products on NDA 203231

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203231Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2022	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203231Orig1s019Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203231Orig1s019ltr.pdf
10/27/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203231s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203231Orig1s015,s016,s017ltr.pdf
10/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203231s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203231Orig1s015,s016,s017ltr.pdf
10/27/2020	SUPPL-15	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203231Orig1s015,s016,s017ltr.pdf
02/02/2017	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203231s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203231Orig1s013ltr.pdf
03/25/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203231Orig1s011ltr.pdf
10/08/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203231Orig1s010ltr.pdf
08/31/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/31/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/10/2014	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
12/10/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
12/10/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf
03/11/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/02/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s002ltr.pdf
02/07/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203231

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203231Orig1s019Lbl.pdf
04/05/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203231Orig1s019Lbl.pdf
10/27/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203231s015s016s017lbl.pdf
10/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203231s015s016s017lbl.pdf
02/02/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203231s013lbl.pdf
03/25/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf
10/08/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf
12/10/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
12/10/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
12/10/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf
05/02/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf
08/02/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf

Therapeutic Equivalents for NDA 203231

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLEDRONIC	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205749	GLAND PHARMA LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210174	AMNEAL
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	203231	INFORLIFE

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