Details for New Drug Application (NDA): 216424
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NDA 216424 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Brooks Steriscience, Daewoong Pharm Co, Eugia Pharma, Gland, Hospira Inc, Hq Spclt Pharma, Qilu, Sandoz, Savior Lifetec Corp, and B Braun Medical Inc, and is included in fourteen NDAs. It is available from fourteen suppliers. Additional details are available on the MEROPENEM profile page.
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.
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.
Suppliers and Packaging for NDA: 216424
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEROPENEM | meropenem | INJECTABLE;INJECTION | 216424 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9430 | 0143-9430-10 | 10 VIAL in 1 CARTON (0143-9430-10) / 20 mL in 1 VIAL (0143-9430-01) |
| MEROPENEM | meropenem | INJECTABLE;INJECTION | 216424 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9431 | 0143-9431-10 | 10 VIAL in 1 CARTON (0143-9431-10) / 30 mL in 1 VIAL (0143-9431-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Jul 22, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Jul 22, 2024 | TE: | AP | RLD: | No | ||||
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