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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017058
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 40MG TABLET, FOR SUSPENSION;ORAL Prescription AA 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
03/14/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

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-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017058s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017058Orig1s028ltr.pdf
06/02/2021 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017058s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017058Orig1s027ltr.pdf
10/07/2019 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017058s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017058Orig1s026ltr.pdf
02/01/2018 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017058s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017058Orig1s025ltr.pdf
12/16/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017058Orig1s022,s023ltr.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017058Orig1s022,s023ltr.pdf
09/19/2013 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017058Orig1s021ltr.pdf
08/24/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
02/04/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017058s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017058s019ltr.pdf
12/07/2006 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017058s017ltr.pdf
09/18/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/30/1999 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/22/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
09/28/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
10/31/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
10/10/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
01/28/1986 SUPPL-6 Labeling

Label is not available on this site.
04/25/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
03/25/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/1977 SUPPL-2 Labeling

Label is not available on this site.
05/04/1976 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017058s028lbl.pdf
06/02/2021 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017058s027lbl.pdf
10/07/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017058s026lbl.pdf
02/01/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017058s025lbl.pdf
12/16/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf
12/16/2016 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017058s022s023lbl.pdf
09/19/2013 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf
02/04/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017058s019lbl.pdf
12/07/2006 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf

METHADONE HYDROCHLORIDE

TABLET, FOR SUSPENSION;ORAL; 40MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 40MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AA 017058 HIKMA
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 40MG TABLET, FOR SUSPENSION;ORAL Prescription No AA 077142 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 40MG TABLET, FOR SUSPENSION;ORAL Prescription No AA 075082 VISTAPHARM
METHADOSE METHADONE HYDROCHLORIDE 40MG TABLET, FOR SUSPENSION;ORAL Prescription No AA 074184 SPECGX LLC
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