PROPRANOLOL HYDROCHLORIDE | N016419 | BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ROXANE LABORATORIES, INC FDA-1985-P-0240 · 3 docket documents 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, INC |
Verex Laboratories Inc. - Citizen Petition FDA-1985-P-0019 · 5 docket documents Verex Laboratories, Inc. filed this citizen petition under 21 CFR 10.30 and Section 314.2(c)(d) on March 20, 1985, requesting that the FDA Commissioner find an Abbreviated New Drug Application suitable for propranolol HCl 160 mg constant-release-rate tablets marketed as PROBLOK, a tablet formulation | Other | 2012-09-06 | Granted | — |
Citizen Petition from Flemington Pharmaceutical Corporation FDA-1992-P-0493 · 5 docket documents Flemington Pharmaceutical Corporation filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.55(d) requesting permission to file an Abbreviated New Drug Application for effervescent propranolol hydrochloride tablets 40 mg, which differs from | Other | 2008-10-15 | Withdrawn | Flemington Pharmaceutical Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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