Potassium Phosphates injections were previously marketed as unapproved product.
Till date, two companies (CMP development and Fresenius Kabi) have received FDA approval from USFDA to market their 505(b)(2)s of Potassium Phosphates injections. Both of these products are indicated as a source of Phosphorus. Potassium Phosphates of CMP development requires to be stored in refrigerated condition. While, Fresenius' product can be stored at room temperature.
See below comparison between Potassium Phosphates injections by CMP development and Fresenius:
Read more on other 505(b)(2) approvals summary here
Fulvestrant 505(b)(2) approval summary
Bortezomib 505(b)(2) approval summary
Teriparatide injection (Pfenex) 505(b)(2) approval summary
Glucagon 505(b)(2) approval summary
Phenylephrine RTU injection 505(b)(2) approval summary
Till date, two companies (CMP development and Fresenius Kabi) have received FDA approval from USFDA to market their 505(b)(2)s of Potassium Phosphates injections. Both of these products are indicated as a source of Phosphorus. Potassium Phosphates of CMP development requires to be stored in refrigerated condition. While, Fresenius' product can be stored at room temperature.
See below comparison between Potassium Phosphates injections by CMP development and Fresenius:
Read more on other 505(b)(2) approvals summary here
Fulvestrant 505(b)(2) approval summary
Bortezomib 505(b)(2) approval summary
Teriparatide injection (Pfenex) 505(b)(2) approval summary
Glucagon 505(b)(2) approval summary
Phenylephrine RTU injection 505(b)(2) approval summary
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