Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087393
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA No 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
05/22/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-46 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-44 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-43 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-41 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-38 REMS-Modified

Label is not available on this site.

12/15/2016 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

06/26/2015 SUPPL-36 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-35 REMS-Modified

Label is not available on this site.

04/16/2014 SUPPL-33 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087393Orig1s033lbl.pdf
04/15/2013 SUPPL-32 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-31 REMS-Proposal

Label is not available on this site.

07/09/2012 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

01/02/2008 SUPPL-28 Labeling

Label is not available on this site.

06/07/2007 SUPPL-27 Labeling

Label is not available on this site.

11/17/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/17/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/10/1991 SUPPL-16 Labeling

Label is not available on this site.

04/02/1991 SUPPL-14 Labeling

Label is not available on this site.

07/17/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/23/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/04/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/06/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2014 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087393Orig1s033lbl.pdf

METHADONE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 087393 HIKMA
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207537 PHARM ASSOC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 090707 VISTAPHARM

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