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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021648
Company: HIKMA

Products on NDA 021648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2004	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21648ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2024	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021648s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021648Orig1s015ltr.pdf
04/14/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021648s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021648Orig1s013ltr.pdf
08/24/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021648s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021648Orig1s011ltr.pdf
12/01/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021648s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021648Orig1s009ltr.pdf
07/28/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021648Orig1s008ltr.pdf
07/03/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/27/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021648Orig1s006ltr.pdf
11/18/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s005ltr.pdf
09/26/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021648Orig1REVs004.pdf

Labels for NDA 021648

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021648s013lbl.pdf
04/25/2024	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021648s015lbl.pdf
04/25/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021648s015lbl.pdf
08/24/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021648s011lbl.pdf
12/01/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021648s009lbl.pdf
07/28/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf
09/27/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf
11/18/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf
09/26/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf
08/26/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf

Therapeutic Equivalents for NDA 021648

DIGOXIN

ELIXIR;ORAL; 0.05MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	No	AA	215209	AMICI PHARMA
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	Yes	AA	021648	HIKMA
DIGOXIN	DIGOXIN	0.05MG/ML	ELIXIR;ORAL	Prescription	No	AA	213000	VISTAPHARM LLC

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