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BROMDAY از شرکت BAUSCH AND LOMB INC

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BROMDAY از شرکت BAUSCH AND LOMB INC

New Drug Application (NDA): 021664

Company: BAUSCH AND LOMB INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROMDAY BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued

None

Yes No
XIBROM BROMFENAC SODIUM EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued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
03/24/2005 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021664ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021664s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/27/2014 SUPPL-19 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf

01/27/2014 SUPPL-14 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf

10/16/2010 SUPPL-13 Efficacy-New Dosing Regimen

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021664s013ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021664Orig1s013.pdf

06/02/2009 SUPPL-10 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf

01/27/2006 SUPPL-1 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2014 SUPPL-19

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
01/27/2014 SUPPL-14

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf
10/16/2010 SUPPL-13

Efficacy-New Dosing Regimen

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf
06/02/2009 SUPPL-10

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf
01/27/2006 SUPPL-1

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf
03/24/2005 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf
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