Details for New Drug Application (NDA): 061395
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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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