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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021516
Company: BAUSCH AND LOMB

Products on NDA 021516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISTALOL	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21516_istalol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21516ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021516s000_IstalolTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/15/2012	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/17/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021516s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021516Orig1s005ltr.pdf

Labels for NDA 021516

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021516s005lbl.pdf
06/04/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21516_istalol_lbl.pdf

Therapeutic Equivalents for NDA 021516

ISTALOL

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISTALOL	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT2	021516	BAUSCH AND LOMB
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	216653	SOMERSET THERAPS LLC

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