Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090577

« Back to Dashboard
NDA 090577 describes IMIPENEM AND CILASTATIN, which is a drug marketed by Hospira Inc and Acs Dobfar and is included in three NDAs. It is available from three suppliers. Additional details are available on the IMIPENEM AND CILASTATIN profile page.

The generic ingredient in IMIPENEM AND CILASTATIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.

Summary for NDA: 090577

Acs Dobfar
cilastatin sodium; imipenem
Therapeutic Class:Antibacterials

Pharmacology for NDA: 090577

Mechanism of ActionDipeptidase Inhibitors

Suppliers and Packaging for NDA: 090577

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cilastatin sodium; imipenem
POWDER;INTRAVENOUS 090577 ANDA Cardinal Health 55154-9389 55154-9389-5 5 VIAL, GLASS in 1 BAG (55154-9389-5) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
cilastatin sodium; imipenem
POWDER;INTRAVENOUS 090577 ANDA Fresenius Kabi USA, LLC 63323-322 63323-322-94 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-94) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No

Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.