CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | N018681 | B BRAUN MEDICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
B. Braun Medical, Inc. - Citizen Petition FDA-2011-P-0550 · 3 docket documents B. Braun Medical Inc. filed a suitability petition under 21 CFR 314.93 and Section 505(j)(2)(c) requesting FDA approval to supplement ANDA 18-681 for Lactated Ringers for Irrigation by adding a 3-liter large volume parenteral package size via prior approval supplement, a size not covered under the c | Other | 2011-08-05 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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