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. Fifteen 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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