Details for New Drug Application (NDA): 062738
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NDA 062738 describes AMPICILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Istituto Bio Ita Spa, Lilly, Onesource Specialty, Sagent Pharms Inc, Sandoz, and Watson Labs Inc, and is included in twenty-five NDAs. It is available from eighteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 062738
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Sandoz |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062738
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | POWDER;INTRAVENOUS | 062738 | ANDA | Sandoz Inc | 0781-3412 | 0781-3412-92 | 10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15) |
| AMPICILLIN SODIUM | ampicillin sodium | POWDER;INTRAVENOUS | 062738 | ANDA | Sandoz Inc | 0781-3413 | 0781-3413-92 | 10 VIAL, GLASS in 1 PACKAGE (0781-3413-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3413-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Feb 19, 1987 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Feb 19, 1987 | TE: | RLD: | No | |||||
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