DICLOXACILLIN SODIUM - Generic Drug Details
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What are the generic sources for dicloxacillin sodium and what is the scope of freedom to operate?
Dicloxacillin sodium
is the generic ingredient in four branded drugs marketed by Aurobindo Pharma, Sandoz, Teva, Glaxosmithkline, Wyeth Ayerst, and Apothecon, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for dicloxacillin sodium. Seven suppliers are listed for this compound.
Summary for DICLOXACILLIN SODIUM
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 9 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 1 |
Patent Applications: | 5,759 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in DICLOXACILLIN SODIUM? | DICLOXACILLIN SODIUM excipients list |
DailyMed Link: | DICLOXACILLIN SODIUM at DailyMed |
Recent Clinical Trials for DICLOXACILLIN 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 DICLOXACILLIN SODIUM
Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for DICLOXACILLIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for DICLOXACILLIN SODIUM
US Patents and Regulatory Information for DICLOXACILLIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | DYNAPEN | dicloxacillin sodium | FOR SUSPENSION;ORAL | 050337-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 061454-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 216845-002 | Sep 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline | DYCILL | dicloxacillin sodium | CAPSULE;ORAL | 060254-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | DICLOXACILLIN SODIUM | dicloxacillin sodium | CAPSULE;ORAL | 061454-002 | 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 |
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