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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019814
Company: ALLERGAN

Products on NDA 019814

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAGAN	LEVOBUNOLOL HYDROCHLORIDE	0.25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1989	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
03/19/2003	SUPPL-17	Labeling		Label is not available on this site.
04/12/2002	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/04/2001	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/12/2001	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/08/2001	SUPPL-12	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf
05/14/2001	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf
10/02/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/01/1998	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/1997	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/12/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/14/1995	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/1995	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/03/1992	SUPPL-3	Labeling		Label is not available on this site.
01/18/1990	SUPPL-2	Labeling		Label is not available on this site.
01/04/1990	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019814

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2001	SUPPL-12	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf
05/14/2001	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf

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