Sodium tetradecyl sulfate - Generic Drug Details
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What are the generic sources for sodium tetradecyl sulfate and what is the scope of freedom to operate?
Sodium tetradecyl sulfate
is the generic ingredient in two branded drugs marketed by Hikma, Elkins Sinn, and Mylan Institutional, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for sodium tetradecyl sulfate. Three suppliers are listed for this compound.
Summary for sodium tetradecyl sulfate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 9 |
| Patent Applications: | 5,688 |
| What excipients (inactive ingredients) are in sodium tetradecyl sulfate? | sodium tetradecyl sulfate excipients list |
| DailyMed Link: | sodium tetradecyl sulfate at DailyMed |
Recent Clinical Trials for sodium tetradecyl sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Goldman, Butterwick, Fitzpatrick and Groff | Phase 2 |
| Combined Military Hospital, Pakistan | Early Phase 1 |
| Oulu University Hospital | N/A |
Medical Subject Heading (MeSH) Categories for sodium tetradecyl sulfate
Anatomical Therapeutic Chemical (ATC) Classes for sodium tetradecyl sulfate
US Patents and Regulatory Information for sodium tetradecyl sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541-001 | Nov 12, 2004 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Elkins Sinn | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 005970-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Elkins Sinn | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 005970-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | SODIUM TETRADECYL SULFATE | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 209937-001 | Dec 9, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Institutional | SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541-002 | Nov 12, 2004 | AP | RX | No | Yes | ⤷ 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 |
