Details for New Drug Application (NDA): 019463

« Back to Dashboard

NDA 019463 describes TIMOPTIC IN OCUDOSE, which is a drug marketed by Aton and is included in one NDA. It is available from two suppliers. Additional details are available on the TIMOPTIC IN OCUDOSE profile page.

The generic ingredient in TIMOPTIC IN OCUDOSE is timolol maleate. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 019463

Tradename:	TIMOPTIC IN OCUDOSE
Applicant:	Aton
Ingredient:	timolol maleate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019463

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 019463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463	NDA	Valeant Pharmaceuticals North America LLC	0187-1496	0187-1496-05	4 POUCH in 1 CARTON (0187-1496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER
TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463	NDA	Valeant Pharmaceuticals North America LLC	0187-1496	0187-1496-99	10 POUCH in 1 CARTON (0187-1496-99) > .3 mL in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Nov 5, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Nov 5, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 019463

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aton	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-001	Nov 5, 1986	➤ Try a Free Trial	➤ Try a Free Trial
Aton	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-001	Nov 5, 1986	➤ Try a Free Trial	➤ Try a Free Trial
Aton	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	➤ Try a Free Trial	➤ Try a Free Trial
Aton	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.