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Details for New Drug Application (NDA): 020312

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NDA 020312 describes UNIVASC, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. Additional details are available on the UNIVASC profile page.

The generic ingredient in UNIVASC is moexipril hydrochloride. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the moexipril hydrochloride profile page.

Summary for NDA: 020312

Tradename:
UNIVASC
Applicant:
Ucb Inc
Ingredient:
moexipril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020312

Suppliers and Packaging for NDA: 020312

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UNIVASC
moexipril hydrochloride
TABLET;ORAL 020312 NDA UCB, Inc. 0091-3707 0091-3707-01 100 TABLET, FILM COATED in 1 BOTTLE (0091-3707-01)
UNIVASC
moexipril hydrochloride
TABLET;ORAL 020312 NDA UCB, Inc. 0091-3707 0091-3707-09 90 TABLET, FILM COATED in 1 BOTTLE (0091-3707-09)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7.5MG
Approval Date:Apr 19, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength15MG
Approval Date:Apr 19, 1995TE:RLD:No

Expired Orange Book Patents for NDA: 020312

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
UNIVASC
moexipril hydrochloride
TABLET;ORAL020312-001Apr 19, 19954,344,949► subscribe
Ucb Inc
UNIVASC
moexipril hydrochloride
TABLET;ORAL020312-002Apr 19, 19954,743,450► subscribe
Ucb Inc
UNIVASC
moexipril hydrochloride
TABLET;ORAL020312-002Apr 19, 19954,344,949► subscribe
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