Details for New Drug Application (NDA): 062719
NDA 062719 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, Lilly, Onesource Specialty, Sagent Pharms Inc, Sandoz, and Watson Labs Inc, and is included in twenty-five NDAs. It is available from fifteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There is one drug master file entry for this compound. Fifteen 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 is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 062719
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Acs Dobfar Spa |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062719 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1595 | 51662-1595-3 | 10 POUCH in 1 CASE (51662-1595-3) / 1 VIAL in 1 POUCH (51662-1595-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062719 | ANDA | Fresenius Kabi USA, LLC | 65219-014 | 65219-014-10 | 10 VIAL in 1 CARTON (65219-014-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-014-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | May 12, 1987 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | May 12, 1987 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | May 12, 1987 | TE: | AP | RLD: | No | ||||
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