Drugs@FDA: FDA-Approved Drugs
Company: ROBINS AH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/25/1983 | 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 |
|---|---|---|---|---|---|
| 11/12/2002 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/07/2001 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf |
| 11/12/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/09/1999 | SUPPL-18 | 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-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/31/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/31/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/21/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/23/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/21/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/20/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/12/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/23/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/12/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |