Competitive Generic Therapies: Off-Patent Drugs With 2 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 |
---|---|---|---|---|---|---|---|---|---|---|
Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-002 | Feb 13, 2024 | RX | Yes | Yes | EQ 2.5GM BASE/PACKET | |
Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-001 | Feb 13, 2024 | RX | Yes | Yes | EQ 500MG BASE/PACKET | |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | RX | Yes | No | EQ 70MG BASE;2,800 IU | |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | RX | Yes | Yes | EQ 70MG BASE;5,600 IU | |
Rising | ALFENTA | alfentanil hydrochloride | INJECTABLE;INJECTION | 019353-001 | Dec 29, 1986 | AP | RX | Yes | Yes | EQ 0.5MG BASE/ML |
Hospira | ALFENTANIL | alfentanil hydrochloride | INJECTABLE;INJECTION | 075221-001 | Oct 28, 1999 | AP | RX | No | No | EQ 0.5MG BASE/ML |
Sandoz Canada Inc | INFUVITE ADULT | alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k | SOLUTION;INTRAVENOUS | 021163-001 | May 18, 2000 | RX | Yes | Yes | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Strength |