Details for New Drug Application (NDA): 207594
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NDA 207594 describes IMIPENEM AND CILASTATIN, which is a drug marketed by Acs Dobfar, Hospira Inc, and Hq Spclt Pharma, and is included in four NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
The generic ingredient in IMIPENEM AND CILASTATIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 207594
| Tradename: | IMIPENEM AND CILASTATIN |
| Applicant: | Hq Spclt Pharma |
| Ingredient: | cilastatin sodium; imipenem |
| Patents: | 0 |
Pharmacology for NDA: 207594
| Mechanism of Action | Dipeptidase Inhibitors |
Suppliers and Packaging for NDA: 207594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMIPENEM AND CILASTATIN | cilastatin sodium; imipenem | POWDER;INTRAVENOUS | 207594 | ANDA | WG Critical Care, LLC | 44567-705 | 44567-705-10 | 10 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL;500MG/VIAL | ||||
| Approval Date: | Dec 12, 2019 | TE: | AP | RLD: | No | ||||
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