Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019270
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/30/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019270Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/05/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/05/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/11/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/25/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/14/2006 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019270s031ltr.pdf
12/04/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/26/1999 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/10/1991 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1990 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/19/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/28/1991 SUPPL-11 Labeling

Label is not available on this site.

08/31/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/13/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/24/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1986 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/04/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2006 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf

BETOPTIC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 075386 AKORN
BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 075630 MEDIMETRIKS PHARMS
BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078694 WOCKHARDT
BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019270 SANDOZ INC

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