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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215143
Company: HIKMA

Products on NDA 215143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215143s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215143Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215143Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143s003lbl.pdf
07/22/2022	SUPPL-2	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215143Orig1s002ltr.pdf
03/17/2022	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215143Orig1s001ltr.pdf

Labels for NDA 215143

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143s003lbl.pdf
03/17/2022	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143Orig1s001Lbl.pdf
08/20/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215143s000lbl.pdf

Therapeutic Equivalents for NDA 215143

SUCCINYLCHOLINE CHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 100MG/5ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	218467	DR REDDYS
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	Yes	AP	215143	HIKMA

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