PROPRANOLOL HYDROCHLORIDE | N016419 | BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ROXANE LABORATORIES, INC FDA-1985-P-0240 Roxane Laboratories, Inc. submitted this petition under Section 314.110(f) of the Food, Drug and Cosmetic Act requesting that the FDA determine ANDA suitability for Propranolol Hydrochloride Oral Solution, 20 mg per 5 ml, arguing that the product offers a valuable alternative dosage form to existing | Other | 2023-10-18 | Granted | ROXANE LABORATORIES |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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