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, 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 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 | Meitheal Pharmaceuticals Inc. | 71288-031 | 71288-031-92 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91) |
| AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065222 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-031 | 71288-031-21 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20) |
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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