Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019425
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANDATE LABETALOL HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/31/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/22/2010 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019425s021ltr.pdf
12/18/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/13/1998 SUPPL-19 Labeling

Label is not available on this site.

05/01/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/20/1994 SUPPL-16 Labeling

Label is not available on this site.

05/27/1993 SUPPL-15 Labeling

Label is not available on this site.

06/05/1991 SUPPL-13 Labeling

Label is not available on this site.

02/01/1991 SUPPL-12 Labeling

Label is not available on this site.

06/07/1990 SUPPL-11 Labeling

Label is not available on this site.

11/07/1990 SUPPL-9 Labeling

Label is not available on this site.

03/23/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1989 SUPPL-7 Labeling

Label is not available on this site.

10/19/1989 SUPPL-6 Labeling

Label is not available on this site.

11/16/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/22/1987 SUPPL-3 Labeling

Label is not available on this site.

05/22/1987 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1986 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
11/22/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf

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