QUELICIN PRESERVATIVE FREE

FDA-2020-P-2317 · 4 docket documents

Baxter Healthcare Corporation petitioned the FDA under 21 CFR §§ 10.25, 10.30, and sections 505(j) and 505(w) of the FDC Act to determine whether Quelicin Preservative Free (Succinylcholine Chloride Injection USP, 20 mg/mL), approved under NDA 008845 and held by Hospira Inc., was withdrawn for safet

FDA-2020-P-2175 · 2 docket documents

Lachman Consulting Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Succinylcholine Chloride Injection in two proposed presentations—100 mg/5 mL (20 mg/mL) and 200 mg/10 mL (20 mg/mL) in single-dose prefilled syringes—suitable for submission as an ANDA

FDA-2019-P-4540 · 3 docket documents

Foley & Lardner LLP filed an ANDA Suitability Petition under section 505(j)(2)(C) requesting approval to submit an Abbreviated New Drug Application for Succinylcholine Chloride Injection USP at 20mg/mL in 5 mL vials (100mg total), which is qualitatively and quantitatively identical to the reference

FDA-2018-P-1238 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Succinylcholine Chloride Injection 100 mg/5 mL in single dose prefilled syringes suitable for submission as an ANDA, referencing QUELICIN (Succinylcholine Chloride) Injection 200 mg/10 mL as t