NAFCILLIN SODIUM - Generic Drug Details
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What are the generic sources for nafcillin sodium and what is the scope of freedom to operate?
Nafcillin sodium
is the generic ingredient in five branded drugs marketed by Wyeth Ayerst, Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Sagent Pharms, Sandoz, Steriscience Speclts, Watson Labs Inc, Glaxosmithkline, and Baxter Hlthcare, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for nafcillin sodium. Ten suppliers are listed for this compound.
Summary for NAFCILLIN SODIUM
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 12 |
NDAs: | 23 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 1 |
Patent Applications: | 2,805 |
What excipients (inactive ingredients) are in NAFCILLIN SODIUM? | NAFCILLIN SODIUM excipients list |
DailyMed Link: | NAFCILLIN SODIUM at DailyMed |
Recent Clinical Trials for NAFCILLIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for NAFCILLIN SODIUM
Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for NAFCILLIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for NAFCILLIN SODIUM
US Patents and Regulatory Information for NAFCILLIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eugia Pharma Speclts | NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 091614-001 | Dec 26, 2012 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wyeth Ayerst | UNIPEN | nafcillin sodium | INJECTABLE;INJECTION | 050320-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Glaxosmithkline | NALLPEN | nafcillin sodium | INJECTABLE;INJECTION | 062755-002 | Dec 19, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Wyeth Ayerst | UNIPEN | nafcillin sodium | INJECTABLE;INJECTION | 050320-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs Inc | NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 062844-002 | Oct 26, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Steriscience Speclts | NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 200002-002 | Apr 7, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Steriscience Speclts | NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 200002-001 | Apr 7, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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