STERILE WATER FOR INJECTION | N019633 | B BRAUN MEDICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
B. Braun Medical, Inc. - Citizen Petition FDA-2011-P-0551 · 5 docket documents B. Braun Medical Inc. filed this suitability petition under 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine it is suitable to supplement ANDA 019633 via prior approval supplement to add 2 liter and 3 liter pharmacy bulk package size | Other | 2011-08-15 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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