STERILE WATER FOR IRRIGATION | N016734 | B BRAUN MEDICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Fresenius Kabi USA, LLC FDA-2023-P-4331 · 7 docket documents Fresenius Kabi USA, LLC filed a suitability petition under 21 CFR 314.93 and Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for Sterile Water for Irrigation, USP in 250 mL and 1500 mL single dose flexible plastic containers, representing a change in strength and total | Suitability | 2023-10-03 | Denied | Fresenius Kabi USA, LLC |
Suitability Petition from Fresenius Kabi USA, LLC FDA-2019-P-6047 · 6 docket documents Fresenius Kabi USA, LLC filed this suitability petition pursuant to Section 505(j)(2)(C) requesting FDA approval to submit an Abbreviated New Drug Application for Sterile Water for Irrigation, USP in 250 mL and 1500 mL fill sizes in flexible plastic containers, representing a change in strength from | Suitability | 2019-12-26 | Open | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.