Details for New Drug Application (NDA): 090579
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NDA 090579 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Medimetriks Pharms, Onesource Specialty, and Sandoz, and is included in twenty-three NDAs. It is available from twelve suppliers. Additional details are available on the AMPICILLIN AND SULBACTAM profile page.
The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are seventy drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are seventy drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 090579
| Tradename: | AMPICILLIN AND SULBACTAM |
| Applicant: | Astral |
| Ingredient: | ampicillin sodium; sulbactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 090579
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 090579
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090579 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-081 | 70594-081-02 | 10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01) |
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090579 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-082 | 70594-082-02 | 10 VIAL in 1 CARTON (70594-082-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-082-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jan 8, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jan 8, 2016 | TE: | RLD: | No | |||||
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