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Details for New Drug Application (NDA): 020545

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NDA 020545 describes PROCANBID, which is a drug marketed by King Pharms and is included in one NDA. Additional details are available on the PROCANBID profile page.

The generic ingredient in PROCANBID is procainamide hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.

Summary for NDA: 020545

Tradename:
PROCANBID
Applicant:
King Pharms
Ingredient:
procainamide hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 31, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Jan 31, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020545

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms
PROCANBID
procainamide hydrochloride
TABLET, EXTENDED RELEASE;ORAL020545-002Jan 31, 19965,656,296► subscribe
King Pharms
PROCANBID
procainamide hydrochloride
TABLET, EXTENDED RELEASE;ORAL020545-001Jan 31, 19965,656,296► subscribe
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