Details for New Drug Application (NDA): 061395
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NDA 061395 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, Sagent Pharms Inc, Sandoz, Steriscience, 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 061395
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Sandoz |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 061395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 061395 | ANDA | Hospira, Inc | 0409-3718 | 0409-3718-01 | 10 VIAL, GLASS in 1 PACKAGE (0409-3718-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0409-3718-10) |
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 061395 | ANDA | Hospira, Inc | 0409-3725 | 0409-3725-01 | 10 VIAL, PHARMACY BULK PACKAGE in 1 PACKAGE (0409-3725-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0409-3725-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 125MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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