Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018821
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METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None Yes No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
11/07/2001 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf
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.

10/21/1985 SUPPL-6 Labeling

Label is not available on this site.

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.

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