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Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

… Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# … 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters … such as operating machinery or driving a motor vehicle. Amantadine has a precaution in its prescribing indication …

FDA Investigates Animal Illnesses Linked to Jerky Pet Treats

… sulfanomides, quinolones, and tetracyclines) Antivirals (amantadine, rimantadine, oseltamivir, and others) Mold and … treat samples and identified 27 that tested positive for amantadine. FDA did not request a recall of these treats … and/or antibiotic residues. FDA does not believe that amantadine contributed to the illnesses because the known …

January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… FDA is evaluating the need for regulatory action. Gocovri (amantadine) Osmolex ER (amantadine)   Corneal oedema FDA is evaluating the need for …

Influenza (Flu) Antiviral Drugs and Related Information

… as generic) Xofluza (baloxavir marboxil) Two older drugs, amantadine (generic) and rimantadine (Flumadine and generic) … to these drugs. CDC has not recommended the use of amantadine and rimantadine for recently circulating influenza …

First Generic Drug Approvals

… opioid dosage escalation for palliative care 54 214897 Amantadine Extended-Release Capsules, 68.5 mg Zydus Worldwide DMCC Gocovri (Amantadine) Extended-Release Capsules 8/26/2024 For the …

Olgica Ceric

… Determination and confirmation of the antiviral drug amantadine and its analogues in chicken jerky pet treats. …

Bulk Drug Substances Reviewed and Not Listed

… a patient-specific prescription can be filled, if needed. Amantadine (3/25/2025) dog, cat, horse any any Amantadine should not be needed urgently to avoid animal suffering or death. FDA-approved animal  drugs and amantadine drugs FDA-approved for use in humans could be used …

Drug-Induced Liver Injury Severity and Toxicity (DILIst) Dataset

… 1 Oral 236 alprazolam 1 Oral 237 altretamine 0 Oral 238 amantadine 0 Oral 239 4-aminosalicylic acid 1 Oral 240 …

Upcoming Product-Specific Guidances for Generic Drug Product Development

… to align with ICH M13A Non-Complex 06/2025 Newly Added Amantadine Hydrochloride Oral Capsule, Extended Release …

Drug Induced Liver Injury Rank (DILIrank) Dataset

… Warnings and precautions Ambiguous DILI-concern 2 LT00503 amantadine 3 Warnings and precautions Ambiguous DILI-concern …

September 2023: Additions and Deletions to the Drug Product List

… 075196 001 001 Apr 30, 1999 Apr 30, 1999 Sep Sep CAHN CAHN AMANTADINE HYDROCHLORIDE > D> > A> > A> > D> > A> > D> AB AB AA AA AB AB CAPSULE;ORAL AMANTADINE HYDROCHLORIDE NOVELGENIX THERAPS RISING SYRUP;ORAL AMANTADINE HYDROCHLORIDE ELYSIUM NOVELGENIX THERAPS …

September 2023: Additions and Deletions to the Drug Product List

… 075196 001 001 Apr 30, 1999 Apr 30, 1999 Sep Sep CAHN CAHN AMANTADINE HYDROCHLORIDE > D> > A> > A> > D> > A> > D> AB AB AA AA AB AB CAPSULE;ORAL AMANTADINE HYDROCHLORIDE NOVELGENIX THERAPS RISING SYRUP;ORAL AMANTADINE HYDROCHLORIDE ELYSIUM NOVELGENIX THERAPS …

May 2017: Additions and Deletions to the Drug Product List (PDF)

… CAHN > A> +! 0.04MG/VIAL N020649 007 Jul 30, 1998 May CAHN AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB HERITAGE PHARMA 100MG … PHARMA 100MG A209047 001 Jun 07, 2017 May NEWA SYRUP;ORAL AMANTADINE HYDROCHLORIDE > D> AA ! PHARM ASSOC 50MG/5ML …

June 2017: Additions and Deletions to the Drug Product List

… CAHN Jun CAHN Jun CAHN Jun CAHN Jun CAHN Jun CAHN Jun CAHN AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB ALEMBIC PHARMS LTD 100MG … 27 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMANTADINE HYDROCHLORIDE TABLET;ORAL AMANTADINE HYDROCHLORIDE …

September 2021 Additions and Deletions to the Drug Product List (Orange Book)

… EQ 0.083% BASE;0.017% > A> AN ! EQ 0.083% BASE;0.017% AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > D> AB STRIDES PHARMA 100MG > A> BX 100MG SYRUP;ORAL AMANTADINE HYDROCHLORIDE > D> AA INVATECH 50MG/5ML > A> AA …

August 2024: Additions and Deletions to the Drug Product List

… > A> AB ALEMBIC 200MG A 215652 001 Sep 04, 2024 Aug NEWA AMANTADINE HYDROCHLORIDE > A> CAPSULE, EXTENDED RELEASE;ORAL AMANTADINE HYDROCHLORIDE > A> AB ZYDUS GOCOVRI EQ 68.5MG BASE … + ADAMAS OPERATIONS +! + SUPERNUS PHARMS + +! SYRUP;ORAL AMANTADINE HYDROCHLORIDE EQ 68.5MG BASE EQ 137MG BASE EQ …

365_210854 baloxavir CDTL DD clinical prea

… is administered as a single dose. Adamantanes, including amantadine and rimantidine comprise the other class of … (cross-resistance).  Adamantanes: o Two are FDA approved: amantadine and rimantadine. o Both only active against … influenza symptoms compared to placebo. The adamantanes, amantadine and rimantadine, although approved for influenza …

December 2022: Additions and Deletions to the Drug Product List

… DISC > A> @ 0.1%;2.5% A 203790 001 Sep 30, 2015 Dec DISC AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB HUMANWELL PURACAP 100MG A … A> @ 100MG A 208107 001 Dec 06, 2016 Dec DISC TABLET;ORAL AMANTADINE HYDROCHLORIDE > D> AB EDENBRIDGE PHARMS 100MG A …

February 2020 Additions and Deletions to the Drug Product List (Orange Book)

… 214070 001 001 Jan 10, 2023 Jan 10, 2023 Feb Feb CAHN CAHN AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > D> > A> BX AB STRIDES PHARMA TABLET;ORAL AMANTADINE HYDROCHLORIDE 100MG 100MG A 209047 A 209047 001 …

January 2017: Additions and Deletions to the Drug Product List

… A> AB > D> AB AUROBINDO PHARMA USA > D> AB > D> AB > D> AB AMANTADINE HYDROCHLORIDE SYRUP;ORAL SYMMETREL > D> @ ENDO … > A> AP > A> AP > D> > A> > A> AB > A> AB > A> AB > A> AP AMANTADINE HYDROCHLORIDE TABLET;ORAL AMANTADINE HYDROCHLORIDE NEWGEN PHARMS LLC AMIODARONE …

September 2018: Additions and Deletions to the Drug Product List

… ALBENZA > D> +! IMPAX LABS INC 200MG > A> AB +! 200MG AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB GRAVITI PHARMS 100MG > D> AB NEWGEN PHARMS LLC 100MG TABLET;ORAL AMANTADINE HYDROCHLORIDE > A> AB GRAVITI PHARMS 100MG > D> AB …

July 2019: Additions and Deletions to the Drug Product List

… 28 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB UPSHER SMITH LABS 100MG … PHARMA 100MG A070589 001 Aug 05, 1986 Jul CAHN TABLET;ORAL AMANTADINE HYDROCHLORIDE > A> AB ! UPSHER SMITH LABS 100MG …

February 2020: Additions and Deletions to the Drug Product List

… 24 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > A> AB INVATECH 100MG A210129 001 Mar 02, 2020 Feb NEWA TABLET;ORAL AMANTADINE HYDROCHLORIDE > A> AB INVATECH 100MG A210215 001 …

September 2019: Additions and Deletions to the Drug Product List (PDF - 205KB)

… 8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG /ML;660 IU/ML;30MCG/ML AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > D> AB GRAVITI PHARMS 100MG A207570 … PHARMS 100MG A207570 001 Sep 30, 2016 Sep CAHN TABLET;ORAL AMANTADINE HYDROCHLORIDE > D> AB GRAVITI PHARMS 100MG A207571 …

September 2020 Additions and Deletions to the Drug Product List (Orange Book)

… 33 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE > D> AB INVATECH 100MG > A> AB … PHARM EQ 161MG BASE > A> + @ EQ 161MG BASE TABLET;ORAL AMANTADINE HYDROCHLORIDE > D> AB INVATECH 100MG > A> AB …