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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021764
Company: SANDOZ

Products on NDA 021764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QOLIANA	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021764

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021764lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021764s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021764s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/10/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/25/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/27/2012	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021764s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021764s005ltr.pdf
08/03/2010	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021764s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021764s002ltr.pdf

Labels for NDA 021764

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021764s005lbl.pdf
08/03/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021764s002lbl.pdf
05/22/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021764lbl.pdf

Therapeutic Equivalents for NDA 021764

QOLIANA

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	ABBVIE
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215225	ALEMBIC
BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078479	APOTEX
QOLIANA	BRIMONIDINE TARTRATE	0.15%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021764	SANDOZ

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