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Details for New Drug Application (NDA): 020552

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NDA 020552 describes COVERA-HS, which is a drug marketed by Gd Searle Llc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the COVERA-HS profile page.

The generic ingredient in COVERA-HS is verapamil hydrochloride. There are sixteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for NDA: 020552

Tradename:
COVERA-HS
Applicant:
Gd Searle Llc
Ingredient:
verapamil hydrochloride
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Feb 26, 1996TE:BCRLD:Yes
Patent:6,096,339Patent Expiration:Apr 4, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Feb 26, 1996TE:BCRLD:Yes
Patent:6,096,339Patent Expiration:Apr 4, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION

Expired Orange Book Patents for NDA: 020552

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
COVERA-HS
verapamil hydrochloride
TABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 19965,785,994► subscribe
Gd Searle Llc
COVERA-HS
verapamil hydrochloride
TABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 19965,082,668► subscribe
Gd Searle Llc
COVERA-HS
verapamil hydrochloride
TABLET, EXTENDED RELEASE;ORAL020552-002Feb 26, 19965,232,705► subscribe
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