Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019907
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPTIPRANOLOL METIPRANOLOL HYDROCHLORIDE 0.3% SOLUTION/DROPS;OPHTHALMIC 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
12/29/1989 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.

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