.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
Accenture
Dow
Argus Health
Merck
Cerilliant
Boehringer Ingelheim
Cipla
AstraZeneca

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091404

« Back to Dashboard

NDA 091404 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Amneal Pharms, Aurobindo Pharma Ltd, Daewoong Pharm Co, Gland Pharma Ltd, Hospira Inc, Par Sterile Products, Sandoz, Savior Lifetec Corp, and B Braun Medical Inc, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the MEROPENEM profile page.

The generic ingredient in MEROPENEM is meropenem. There are thirty-one drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for 091404

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 091404

Ingredient-typeCarbapenems

Suppliers and Packaging for NDA: 091404

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 091404 ANDA Fresenius Kabi USA, LLC 63323-507 63323-507-21 10 VIAL in 1 CARTON (63323-507-21) > 10 mL in 1 VIAL
MEROPENEM meropenem INJECTABLE;INJECTION 091404 ANDA Fresenius Kabi USA, LLC 63323-507 63323-507-20 10 VIAL in 1 CARTON (63323-507-20) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Queensland Health
Cerilliant
Cantor Fitzgerald
Julphar
Merck
Healthtrust
Fuji
Colorcon

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot