Details for New Drug Application (NDA): 090057
NDA 090057 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, Epic Pharma Llc, Hikma Farmaceutica, Regcon Holdings, 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 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 | |||||
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