Competitive Generic Therapies: Off-Patent Drugs With 3 Sources
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This table lists drugs which, despite having no patents or regulatory protections, have a limited number of active sources.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Strength |
|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Generics | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 202229-001 | Jul 16, 2013 | AB | RX | No | Yes | 333MG |
| Mylan | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 200142-001 | Mar 11, 2014 | AB | RX | No | No | 333MG |
| Zydus Pharms | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 205995-001 | May 26, 2017 | AB | RX | No | No | 333MG |
| Cosette | HYDROCORTISONE AND ACETIC ACID | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 040609-001 | Feb 6, 2006 | AT | RX | No | No | 2%;1% |
| Taro | HYDROCORTISONE AND ACETIC ACID | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 088759-001 | Mar 4, 1985 | AT | RX | Yes | Yes | 2%;1% |
| Saptalis Pharms | VOSOL HC | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 012770-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | 2%;1% |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Strength |
