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IID Quarter 3 – July 2023 Corrections/Replacements and Deletions
… LACTIC ACID SUBCUTANEOUS INJECTION 10 mg R 4171 Q2 2023 LEVOMENTHOL BUCCAL GUM, CHEWING 9.20 mg R 4171 Q3 2023 LEVOMENTHOL BUCCAL GUM, CHEWING 113 mg R 4477 Q2 2023 …
ID Quarter 1 – January 2022 Corrections, Replacements and Deletions
… OIL TOPICAL CREAM 143 mg MDE Replacement 4,225 Q4 2021 LEVOMENTHOL TOPICAL SPRAY 0.05 %w/w MDE Replacement 4,225 Q1 2022 LEVOMENTHOL TOPICAL SPRAY 2 mg MDE Replacement 4,240 Q4 2021 …
IID Quarter 3 – July 2020 Corrections/Replacements and Deletions
… SW-9008 ORAL CAPSULE, EXTENDED RELEASE 0.28 mg Q2 2020 LEVOMENTHOL SUBLINGUAL SPRAY 0.05 mg/ 0.10 ml Q3 2020 LEVOMENTHOL SUBLINGUAL SPRAY 0.05 mg/ 1.00 ml Q2 2020 LIGHT …
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
… • Lactose, spray dried • L-Aspartic Acid Sodium Salt • Levomenthol • Liquid Paraffin • Lysine aspirin Updated …
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
… L-Cysteine • Lecithin Soya Granular • Lecithin Organogel • Levomenthol • Levulose • L-Histidine Monohydrochloride, …
Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions
… • Stereo bonds should point to chiral atoms. See GSRS levomenthol example. • Include stoichiometry explicitly if …
Quick Guide to Creating an SD File
… • Stereo bonds should point to chiral atoms. See GSRS levomenthol example. • Include stoichiometry explicitly if …