Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019907
Company: BAUSCH AND LOMB

Products on NDA 019907

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPTIPRANOLOL	METIPRANOLOL HYDROCHLORIDE	0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No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 019907

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1989	ORIG-1	Approval	Type 1 - New Molecular Entity	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
11/21/2006	SUPPL-25	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019907s025ltr.pdf
07/26/2002	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/30/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
11/06/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/13/1999	SUPPL-12	Labeling		Label is not available on this site.
12/13/1999	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/19/1999	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1998	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/21/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/21/1996	SUPPL-7	Labeling		Label is not available on this site.
10/03/1997	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/19/1996	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/1995	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/11/1995	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/15/1994	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.