Details for New Drug Application (NDA): 091007
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NDA 091007 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 091007
| 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 500MG BASE/VIAL;500MG/VIAL | ||||
| Approval Date: | Nov 16, 2011 | TE: | RLD: | No | |||||
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