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Details for New Drug Application (NDA): 201404
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are sixty-nine drug master file entries for this compound. Seventeen 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 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201404
Ingredient-type | Penicillins |
Medical Subject Heading (MeSH) Categories for 201404
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 | APP Pharmaceuticals, LLC | 63323-404 | E | 63323-404-00 |
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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