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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202565
Company: SANDOZ

Products on ANDA 202565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2015	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202565Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202565Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/01/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202565

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202565Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202565

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.03%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	210263	ALEMBIC
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090449	APOTEX
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	205537	EUGIA PHARMA
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	210126	GLAND PHARMA LTD
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203991	LUPIN LTD
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202505	MICRO LABS
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202565	SANDOZ
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207601	SOMERSET THERAPS LLC

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