Details for New Drug Application (NDA): 202106
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The generic ingredient in MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER is meropenem. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 202106
| Tradename: | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
| Applicant: | B Braun Medical |
| Ingredient: | meropenem |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202106
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | meropenem | POWDER;INTRAVENOUS | 202106 | NDA | B. Braun Medical Inc. | 0264-3183 | 0264-3183-11 | 24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER |
| MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | meropenem | POWDER;INTRAVENOUS | 202106 | NDA | B. Braun Medical Inc. | 0264-3185 | 0264-3185-11 | 24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Apr 30, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1GM/VIAL | ||||
| Approval Date: | Apr 30, 2015 | TE: | RLD: | Yes | |||||
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