Details for New Drug Application (NDA): 090339
✉ Email this page to a colleague
NDA 090339 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, Sandoz, and Steriscience Speclts, and is included in twenty-three NDAs. It is available from eleven 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 090339
| Tradename: | AMPICILLIN AND SULBACTAM |
| Applicant: | Eugia Pharma Speclts |
| Ingredient: | ampicillin sodium; sulbactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 090339
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 090339
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090339 | ANDA | Eugia US LLC | 55150-118 | 55150-118-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090339 | ANDA | Eugia US LLC | 55150-118 | 55150-118-99 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | ||||
| Approval Date: | Sep 20, 2010 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
