Details for New Drug Application (NDA): 019270

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

NDA 019270 describes BETOPTIC, which is a drug marketed by Sandoz Inc, Alcon, and Novartis, and is included in three NDAs. It is available from one supplier. Additional details are available on the BETOPTIC profile page.

The generic ingredient in BETOPTIC is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.

Summary for 019270

Tradename:	BETOPTIC
Applicant:	Sandoz Inc
Ingredient:	betaxolol hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 019270

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 019270

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245	61314-245-01	5 mL in 1 BOTTLE, PLASTIC (61314-245-01)
BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245	61314-245-02	15 mL in 1 BOTTLE, PLASTIC (61314-245-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Aug 30, 1985	TE:	AT	RLD:	Yes

Expired US Patents for NDA 019270

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz Inc	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	See Plans and Pricing	See Plans and Pricing
Sandoz Inc	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	See Plans and Pricing	See Plans and Pricing
Sandoz Inc	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving 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 verification 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.