Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017862s063ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/017862Orig1s063.pdf | |
| 06/30/2009 | SUPPL-61 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017862s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/017862Orig1s061.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 |