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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021624
Company: MYLAN INSTITUTIONAL

Products on NDA 021624

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/1947	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021624s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021624Orig1s016ltr.pdf
05/24/2022	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021624Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021624Orig1s015ltr.pdf
06/02/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021624s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021624Orig1s014ltr.pdf
10/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021624s010lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021624s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021624Orig1s006ltr.pdf
06/26/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/12/2004	SUPPL-1	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21624slr001_methadone_hcl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21624slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021624Orig1s001.pdf

Labels for NDA 021624

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021624s016lbl.pdf
05/24/2022	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021624Orig1s015lbl.pdf
05/24/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021624Orig1s015lbl.pdf
06/02/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021624s014lbl.pdf
10/07/2019	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021624s010lbl.pdf
10/07/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021624s010lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021624s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021624s006lbl.pdf
02/12/2004	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21624slr001_methadone_hcl_lbl.pdf

Therapeutic Equivalents for NDA 021624

METHADONE HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208306	LONG GROVE PHARMS
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	021624	MYLAN INSTITUTIONAL

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