Cloxacillin sodium - Generic Drug Details
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What are the generic drug sources for cloxacillin sodium and what is the scope of freedom to operate?
Cloxacillin sodium
is the generic ingredient in three branded drugs marketed by Apothecon, Teva, and Glaxosmithkline, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for cloxacillin sodium.
Summary for cloxacillin sodium
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 8 |
| Drug Master File Entries: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,527 |
| DailyMed Link: | cloxacillin sodium at DailyMed |
Recent Clinical Trials for cloxacillin 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 |
Medical Subject Heading (MeSH) Categories for cloxacillin sodium
Anatomical Therapeutic Chemical (ATC) Classes for cloxacillin sodium
US Patents and Regulatory Information for cloxacillin sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | CLOXAPEN | cloxacillin sodium | CAPSULE;ORAL | 062233-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | CLOXACILLIN SODIUM | cloxacillin sodium | CAPSULE;ORAL | 062240-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apothecon | TEGOPEN | cloxacillin sodium | FOR SOLUTION;ORAL | 061453-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | CLOXAPEN | cloxacillin sodium | CAPSULE;ORAL | 061806-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apothecon | CLOXACILLIN SODIUM | cloxacillin sodium | CAPSULE;ORAL | 061452-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | CLOXAPEN | cloxacillin sodium | CAPSULE;ORAL | 062233-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apothecon | TEGOPEN | cloxacillin sodium | FOR SOLUTION;ORAL | 050192-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
