Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019219
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAGAN LEVOBUNOLOL HYDROCHLORIDE 0.5% 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
12/19/1985 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019219Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019219Orig1s029ltr.pdf
12/16/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/12/2002 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/04/2001 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/08/2001 SUPPL-20 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf
05/14/2001 SUPPL-19 Labeling

Label is not available on this site.

10/02/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/19/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1992 SUPPL-11 Labeling

Label is not available on this site.

01/31/1990 SUPPL-10 Labeling

Label is not available on this site.

12/06/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1989 SUPPL-7 Labeling

Label is not available on this site.

11/09/1988 SUPPL-5 Labeling

Label is not available on this site.

10/21/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1987 SUPPL-3 Labeling

Label is not available on this site.

09/15/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/22/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf
08/08/2001 SUPPL-20 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf

BETAGAN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKBETA LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074780 AKORN
BETAGAN LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019219 ALLERGAN
LEVOBUNOLOL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074326 BAUSCH AND LOMB

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