Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
McKinsey
Colorcon
Baxter
Boehringer Ingelheim

Last Updated: August 10, 2022

Details for New Drug Application (NDA): 020215


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 020215 describes MONOKET, which is a drug marketed by Eci Pharms Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the MONOKET profile page.

The generic ingredient in MONOKET is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 020215
Tradename:MONOKET
Applicant:Eci Pharms Llc
Ingredient:isosorbide mononitrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020215
Physiological Effect Vasodilation
Suppliers and Packaging for NDA: 020215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONOKET isosorbide mononitrate TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Lannett Company, Inc. 62175-106 62175-106-01 100 TABLET in 1 BOTTLE (62175-106-01)
MONOKET isosorbide mononitrate TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Lannett Company, Inc. 62175-107 62175-107-01 100 TABLET in 1 BOTTLE (62175-107-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 30, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 30, 1993TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Colorcon
McKesson
AstraZeneca
Express Scripts

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 verification 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.