Details for New Drug Application (NDA): 062797
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NDA 062797 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 sixteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 062797
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Istituto Bio Ita Spa |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062797
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062797 | ANDA | Fresenius Kabi USA, LLC | 65219-020 | 65219-020-23 | 10 VIAL in 1 CARTON (65219-020-23) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) |
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062797 | ANDA | Civica, Inc. | 72572-017 | 72572-017-10 | 10 VIAL, GLASS in 1 CARTON (72572-017-10) / 2 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (72572-017-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 125MG BASE/VIAL | ||||
| Approval Date: | Jul 12, 1993 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Jul 12, 1993 | TE: | AP | RLD: | No | ||||
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