Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017854
Company: ANI PHARMS
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 | STRIDES PHARMA |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077878 | STRIDES PHARMA |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 070184 | TEVA |
| 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 | 077878 | STRIDES PHARMA |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 072801 | TEVA |
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 017854 | ANI PHARMS |