Details for New Drug Application (NDA): 065342
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NDA 065342 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Apotex, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Antibiotics, Samson Medcl, Sandoz, Sandoz Inc, Teva, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, Teva Pharms Usa, Wockhardt Bio Ag, B Braun, Baxter Hlthcare, Anda Repository, and Hikma, and is included in thirty-seven NDAs. It is available from fifteen suppliers. Additional details are available on the CEFTRIAXONE profile page.
The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065342
| Tradename: | CEFTRIAXONE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | ceftriaxone sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065342
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065342 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9856 | 0143-9856-25 | 25 VIAL in 1 BOX (0143-9856-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9856-01) |
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065342 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9857 | 0143-9857-25 | 25 VIAL in 1 BOX (0143-9857-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9857-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Jan 10, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jan 10, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jan 10, 2008 | TE: | AP | RLD: | No | ||||
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