Details for New Drug Application (NDA): 090825
NDA 090825 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 is one drug master file entry 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 090825
| Tradename: | IMIPENEM AND CILASTATIN |
| Applicant: | Hospira Inc |
| Ingredient: | cilastatin sodium; imipenem |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 250MG BASE/VIAL;250MG/VIAL | ||||
| Approval Date: | Nov 16, 2011 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL;500MG/VIAL | ||||
| Approval Date: | Nov 16, 2011 | TE: | RLD: | No | |||||
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