Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017862
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
02/07/1979 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2010 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017862s063ltr.pdf
06/30/2009 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017862s061ltr.pdf
04/19/2004 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf
04/19/2004 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf
11/07/2001 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf
01/29/2001 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2001 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2001 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1999 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

03/09/1999 SUPPL-42 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf
01/30/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/01/2000 SUPPL-40 Labeling

Label is not available on this site.

06/24/1996 SUPPL-39 Labeling

Label is not available on this site.

05/31/1994 SUPPL-38 Labeling

Label is not available on this site.

02/16/1990 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1989 SUPPL-36 Labeling

Label is not available on this site.

08/31/1992 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-32 Labeling

Label is not available on this site.

04/17/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1986 SUPPL-30 Labeling

Label is not available on this site.

05/28/1987 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/21/1985 SUPPL-25 Labeling

Label is not available on this site.

08/20/1985 SUPPL-24 Labeling

Label is not available on this site.

03/12/1985 SUPPL-22 Labeling

Label is not available on this site.

05/28/1987 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

07/05/1983 SUPPL-20 Efficacy

Label is not available on this site.

06/14/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/03/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/13/1983 SUPPL-17 Labeling

Label is not available on this site.

01/04/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/12/1982 SUPPL-15 Labeling

Label is not available on this site.

11/02/1982 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/08/1982 SUPPL-13 Labeling

Label is not available on this site.

06/23/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/19/1982 SUPPL-9 Efficacy

Label is not available on this site.

12/09/1981 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/08/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1982 SUPPL-6 Efficacy

Label is not available on this site.

01/25/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-4 Labeling

Label is not available on this site.

01/22/1981 SUPPL-3 Efficacy

Label is not available on this site.

10/16/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1979 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
11/18/2010 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf
06/30/2009 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English