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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020963
Company: SANDOZ

Products on NDA 020963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20963ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020963_timolol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2024	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020963s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020963Orig1s015ltr.pdf
09/25/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/08/2007	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020963s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020963s010ltr.pdf
07/02/2003	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20963slr007_droptainer_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20963slr007ltr.pdf
02/05/2001	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20963s5lbl.pdf
03/09/2000	SUPPL-4	Labeling		Label is not available on this site.
02/18/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/17/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/06/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020963

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020963s015lbl.pdf
06/08/2007	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020963s010lbl.pdf
07/02/2003	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20963slr007_droptainer_lbl.pdf
02/05/2001	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20963s5lbl.pdf
10/21/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20963lbl.pdf

Therapeutic Equivalents for NDA 020963

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	212942	ALEMBIC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	215733	DR REDDYS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	214645	GLAND
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020963	SANDOZ
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	210640	SOMERSET THERAPS LLC
TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020330	BAUSCH AND LOMB INC

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	212942	ALEMBIC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	215733	DR REDDYS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	213540	EUGIA PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	214645	GLAND
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020963	SANDOZ
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	210640	SOMERSET THERAPS LLC
TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020330	BAUSCH AND LOMB INC

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