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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, Akorn Inc, Astral, Cephazone Pharma, Hikma Farmaceutica, Teva Pharms Usa, B Braun, Baxter Hlthcare, and Hikma, and is included in thirty-six NDAs. It is available from twenty 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. Twenty-two 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. Twenty-two 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 |
| Formulation / Manufacturing: | see details |
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 | 25021-105 | 25021-105-66 | 25 VIAL in 1 CARTON (25021-105-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 065329 | ANDA | Sagent Pharmaceuticals | 25021-105 | 25021-105-10 | 25 VIAL in 1 CARTON (25021-105-10) > 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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