Details for New Drug Application (NDA): 205835
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The generic ingredient in MEROPENEM is meropenem. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 205835
| Tradename: | MEROPENEM |
| Applicant: | Eugia Pharma |
| Ingredient: | meropenem |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEROPENEM | meropenem | INJECTABLE;INJECTION | 205835 | ANDA | Eugia US LLC | 55150-207 | 55150-207-20 | 10 VIAL in 1 CARTON (55150-207-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| MEROPENEM | meropenem | INJECTABLE;INJECTION | 205835 | ANDA | Eugia US LLC | 55150-208 | 55150-208-30 | 10 VIAL in 1 CARTON (55150-208-30) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Mar 27, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Mar 27, 2017 | TE: | AP | RLD: | No | ||||
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