Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006134
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AA Yes Yes
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/30ML SYRUP;ORAL Discontinued None No No
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;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
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
09/18/2018 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf
09/18/2018 SUPPL-46 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf
02/01/2018 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s045ltr.pdf
05/26/2017 SUPPL-44 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006134Orig1s044ltr.pdf
09/30/2016 SUPPL-42 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s042ltr.pdf
12/16/2016 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf
04/20/2016 SUPPL-39 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s039ltr.pdf
04/02/2015 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s038ltr.pdf
06/26/2015 SUPPL-37 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s037ltr.pdf
08/19/2014 SUPPL-36 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s036ltr.pdf
04/16/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s035ltr.pdf
04/15/2013 SUPPL-32 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006134Orig1s032ltr.pdf
07/09/2012 SUPPL-31 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s031ltr.pdf
07/09/2012 SUPPL-30 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s030ltr.pdf
11/17/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/06134s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/006134_s028_dolophine_hydrochloride.pdf
05/05/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1999 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/15/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/17/2000 SUPPL-23 Labeling

Label is not available on this site.

02/21/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1999 SUPPL-17 Labeling

Label is not available on this site.

08/13/1987 SUPPL-15 Labeling

Label is not available on this site.

01/10/1986 SUPPL-13 Labeling

Label is not available on this site.

10/16/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/01/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1977 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf
09/18/2018 SUPPL-46 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf
02/01/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf
12/16/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf
04/02/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf
04/16/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf
07/09/2012 SUPPL-31 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf
11/17/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf

DOLOPHINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
METHADOSE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090635 THEPHARMANETWORK LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040241 VISTAPHARM
METHADOSE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

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