Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021262
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPHAGAN P BRIMONIDINE TARTRATE 0.15% 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
03/16/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_AlphaganP.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/13/2010 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf
05/22/2006 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021262s018LTR.pdf
02/10/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf
02/10/2004 SUPPL-10 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf
04/12/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/19/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/20/2001 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm
12/04/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/18/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/23/2001 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
08/13/2010 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf
05/22/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf
12/20/2001 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf
03/16/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf

ALPHAGAN P

SOLUTION/DROPS;OPHTHALMIC; 0.15%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPHAGAN P BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021262 ALLERGAN
QOLIANA BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 021764 SANDOZ INC

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