Details for New Drug Application (NDA): 065222
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NDA 065222 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Eurofarma, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, 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 065222
| Tradename: | AMPICILLIN AND SULBACTAM |
| Applicant: | Istituto Bio Ita Spa |
| Ingredient: | ampicillin sodium; sulbactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 065222
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065222
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065222 | ANDA | NorthStar Rx, LLC | 72603-220 | 72603-220-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01) |
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065222 | ANDA | NorthStar Rx, LLC | 72603-220 | 72603-220-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 29, 2005 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | ||||
| Approval Date: | Nov 29, 2005 | TE: | AP | RLD: | No | ||||
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