Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019972
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUPRESS CARTEOLOL HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
05/23/1990 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
05/22/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/18/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/24/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/22/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1997 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/06/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1996 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1996 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1996 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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