Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017854
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB Yes Yes
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB Yes 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
12/30/1980 ORIG-1 Approval Type 3 - New Dosage Form 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
08/29/2017 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017854s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017854Orig1s062ltr.pdf
06/15/2015 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

04/17/2015 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

09/22/2011 SUPPL-58 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s058ltr.pdf
08/02/2011 SUPPL-56 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s056ltr.pdf
11/18/2010 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf
09/04/2009 SUPPL-52 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf
06/30/2009 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/017854_s051_reglan_tablets.pdf
07/26/2004 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17854s047ltr.pdf
04/22/2003 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr045ltr.pdf
04/22/2003 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr044ltr.pdf
11/07/2001 SUPPL-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf
04/22/2003 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr040ltr.pdf
03/09/1999 SUPPL-39 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf
02/03/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/01/2000 SUPPL-37 Labeling

Label is not available on this site.

06/24/1996 SUPPL-36 Labeling

Label is not available on this site.

05/31/1994 SUPPL-35 Labeling

Label is not available on this site.

02/22/1989 SUPPL-34 Labeling

Label is not available on this site.

08/31/1992 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/21/1986 SUPPL-30 Labeling

Label is not available on this site.

05/05/1987 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/15/1986 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/23/1986 SUPPL-27 Labeling

Label is not available on this site.

01/16/1986 SUPPL-26 Manufacturing (CMC)-Control

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.

01/18/1985 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1985 SUPPL-21 Labeling

Label is not available on this site.

09/21/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1984 SUPPL-19 Labeling

Label is not available on this site.

05/01/1984 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/05/1983 SUPPL-17 Labeling

Label is not available on this site.

05/11/1983 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1983 SUPPL-15 Labeling

Label is not available on this site.

11/12/1982 SUPPL-14 Labeling

Label is not available on this site.

09/08/1982 SUPPL-13 Labeling

Label is not available on this site.

07/27/1983 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/18/1982 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1984 SUPPL-5 Efficacy

Label is not available on this site.

05/13/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-2 Efficacy

Label is not available on this site.

05/13/1981 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/29/2017 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017854s062lbl.pdf
09/22/2011 SUPPL-58 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf
11/18/2010 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf
09/04/2009 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf
09/04/2009 SUPPL-52 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf
06/30/2009 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf
07/26/2004 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf

REGLAN

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 071250 IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078807 IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 070581 PAR PHARM INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 070184 TEVA
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077878 VINTAGE PHARMS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 017854 ANI PHARMS

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 071250 IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078807 IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 072801 TEVA
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 077878 VINTAGE PHARMS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 017854 ANI PHARMS

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