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Details for New Drug Application (NDA): 204139

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NDA 204139 describes MEROPENEM, which is a drug marketed by Sandoz, Acs Dobfar, 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 nine NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for NDA: 204139

Tradename:
MEROPENEM
Applicant:
Par Sterile Products
Ingredient:
meropenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 204139

Ingredient-typeCarbapenems

Suppliers and Packaging for NDA: 204139

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM
meropenem
INJECTABLE;INJECTION 204139 ANDA Par Pharmaceutical, Inc. 42023-191 42023-191-10 10 VIAL in 1 CARTON (42023-191-10) > 20 mL in 1 VIAL (42023-191-01)
MEROPENEM
meropenem
INJECTABLE;INJECTION 204139 ANDA Par Pharmaceutical, Inc. 42023-192 42023-192-10 10 VIAL in 1 CARTON (42023-192-10) > 30 mL in 1 VIAL (42023-192-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Jun 9, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Jun 9, 2016TE:APRLD:No


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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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