COLISTIN SULFATE - Generic Drug Details
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What are the generic drug sources for colistin sulfate and what is the scope of freedom to operate?
Colistin sulfate
is the generic ingredient in one branded drug marketed by Parke Davis and Endo Operations, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for colistin sulfate.
Summary for COLISTIN SULFATE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 4 |
| Clinical Trials: | 5 |
| DailyMed Link: | COLISTIN SULFATE at DailyMed |
Recent Clinical Trials for COLISTIN SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Madonna Magdy Fahmy | Early Phase 1 |
| National Cancer Institute, Egypt | Phase 4 |
| Cystic Fibrosis Foundation | Phase 1/Phase 2 |
Medical Subject Heading (MeSH) Categories for COLISTIN SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for COLISTIN SULFATE
US Patents and Regulatory Information for COLISTIN SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | COLY-MYCIN S | colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide | SUSPENSION/DROPS;OTIC | 050356-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Parke Davis | COLY-MYCIN S | colistin sulfate | SUSPENSION;ORAL | 050355-001 | 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 |
