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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205883

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NDA 205883 describes MEROPENEM, which is a drug marketed by Sandoz, Acs Dobfar, Aurobindo Pharma Ltd, Par Sterile Products, Hospira Inc, Gland Pharma Ltd, Daewoong Pharm Co, Amneal Pharms, 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 NDA: 205883

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

Pharmacology for NDA: 205883

Ingredient-typeCarbapenems

Suppliers and Packaging for NDA: 205883

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM
meropenem
INJECTABLE;INJECTION 205883 ANDA BluePoint Laboratories 68001-323 68001-323-31 10 VIAL, GLASS in 1 CARTON (68001-323-31) > 20 mL in 1 VIAL, GLASS (68001-323-29)
MEROPENEM
meropenem
INJECTABLE;INJECTION 205883 ANDA BluePoint Laboratories 68001-324 68001-324-57 10 VIAL, GLASS in 1 CARTON (68001-324-57) > 30 mL in 1 VIAL, GLASS (68001-324-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Apr 12, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Apr 12, 2016TE:APRLD:No


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Fuji
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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.

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