Details for New Drug Application (NDA): 201404
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NDA 201404 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 Speclts, 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 201404
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Istituto Bio Ita Spa |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201404
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 201404 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-118 | 70860-118-99 | 1 BOTTLE in 1 CARTON (70860-118-99) / 100 mL in 1 BOTTLE |
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 201404 | ANDA | NorthStar Rx, LLC | 72603-578 | 72603-578-01 | 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (72603-578-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Dec 20, 2013 | TE: | AP | RLD: | No | ||||
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