Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021624
Company: MYLAN INSTITUTIONAL
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 AKORN
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 021624 MYLAN INSTITUTIONAL

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