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Details for New Drug Application (NDA): 021398

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NDA 021398 describes COMBIGAN, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COMBIGAN profile page.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for NDA: 021398

Tradename:
COMBIGAN
Applicant:
Allergan
Ingredient:
brimonidine tartrate; timolol maleate
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 021398

Suppliers and Packaging for NDA: 021398

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC 021398 NDA Allergan, Inc. 0023-9211 0023-9211-03 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) > 2.5 mL in 1 BOTTLE, DROPPER
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC 021398 NDA Allergan, Inc. 0023-9211 0023-9211-05 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%;EQ 0.5% BASE
Approval Date:Oct 30, 2007TE:RLD:Yes
Patent:7,323,463Patent Expiration:Jan 19, 2023Product Flag?YSubstance Flag?Delist Request?Y
Patent:8,748,425Patent Expiration:Apr 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent:9,474,751Patent Expiration:Apr 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE


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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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