Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089897
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE INTENSOL METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/06/1988 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
09/18/2018 SUPPL-39 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-38 REMS-Modified

Label is not available on this site.

06/27/2017 SUPPL-36 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/30/2016 SUPPL-35 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-34 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-32 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-31 REMS-Modified

Label is not available on this site.

04/16/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/089897Orig1s028lbl.pdf
04/15/2013 SUPPL-27 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-26 REMS-Proposal

Label is not available on this site.

07/09/2012 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

08/27/2008 SUPPL-22 Labeling

Label is not available on this site.

01/14/2008 SUPPL-21 Labeling

Label is not available on this site.

01/14/2008 SUPPL-20 Labeling

Label is not available on this site.

12/12/2007 SUPPL-19 Labeling

Label is not available on this site.

05/09/2007 SUPPL-18 Labeling

Label is not available on this site.

03/21/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/29/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/29/1997 SUPPL-7 Labeling

Label is not available on this site.

01/29/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/23/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 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
04/16/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/089897Orig1s028lbl.pdf

METHADONE HYDROCHLORIDE INTENSOL

CONCENTRATE;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 207368 PHARM ASSOC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 040088 VISTAPHARM
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 040180 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE INTENSOL METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 089897 WEST-WARD PHARMS INT
METHADOSE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription Yes AA 017116 SPECGX LLC

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