Details for New Drug Application (NDA): 065329
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NDA 065329 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, Teva Pharms Usa, B Braun, Baxter Hlthcare, Anda Repository, and Hikma, and is included in thirty-seven NDAs. It is available from fourteen suppliers. Additional details are available on the CEFTRIAXONE profile page.
The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Sixteen 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 are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065329
| Tradename: | CEFTRIAXONE |
| Applicant: | Acs Dobfar |
| Ingredient: | ceftriaxone sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065329
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | Sagent Pharmaceuticals | 25021-106 | 25021-106-10 | 25 VIAL in 1 CARTON (25021-106-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | Sagent Pharmaceuticals | 25021-107 | 25021-107-20 | 25 VIAL in 1 CARTON (25021-107-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jul 24, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jul 24, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Jul 24, 2008 | TE: | AP | RLD: | No | ||||
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