Details for New Drug Application (NDA): 090057
✉ Email this page to a colleague
NDA 090057 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. 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 are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 090057
| Tradename: | CEFTRIAXONE |
| Applicant: | Samson Medcl |
| Ingredient: | ceftriaxone sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090057
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INJECTION | 090057 | ANDA | Samson Medical Technologies, LLC | 66288-6100 | 66288-6100-1 | 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100GM BASE/VIAL | ||||
| Approval Date: | Apr 25, 2014 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
