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Details for New Drug Application (NDA): 020439

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NDA 020439 describes BETIMOL, which is a drug marketed by Oak Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the BETIMOL profile page.

The generic ingredient in BETIMOL is timolol. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the timolol profile page.

Summary for NDA: 020439

Tradename:
BETIMOL
Applicant:
Oak Pharms Inc
Ingredient:
timolol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020439

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 020439

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETIMOL
timolol
SOLUTION/DROPS;OPHTHALMIC 020439 NDA Vistakon Pharmaceuticals LLC 68669-522 68669-522-05 5 mL in 1 BOTTLE (68669-522-05)
BETIMOL
timolol
SOLUTION/DROPS;OPHTHALMIC 020439 NDA Vistakon Pharmaceuticals LLC 68669-525 68669-525-05 5 mL in 1 BOTTLE (68669-525-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Mar 31, 1995TE:ATRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Mar 31, 1995TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 020439

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
BETIMOL
timolol
SOLUTION/DROPS;OPHTHALMIC020439-001Mar 31, 19955,231,095► subscribe
Oak Pharms Inc
BETIMOL
timolol
SOLUTION/DROPS;OPHTHALMIC020439-002Mar 31, 19955,231,095► subscribe
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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.

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