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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019425
Company: SEBELA IRELAND LTD

Products on NDA 019425

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TRANDATE	LABETALOL HYDROCHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019425

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.

Labels for NDA 019425

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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