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Details for New Drug Application (NDA): 091613
The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.
Summary for 091613
Tradename: | NAFCILLIN SODIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | nafcillin sodium |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091613
Ingredient-type | Penicillins |
Medical Subject Heading (MeSH) Categories for 091613
Suppliers and Packaging for NDA: 091613
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 091613 | ANDA | AuroMedics Pharma LLC | 55150-122 | N | 55150-122-15 |
NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 091613 | ANDA | AuroMedics Pharma LLC | 55150-123 | N | 55150-123-16 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Dec 26, 2012 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
Approval Date: | Dec 26, 2012 | TE: | AP | RLD: | No |
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