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06/09/2026 - FDA posts final administrative order (OTC000039)
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter
Human Use, and Related Information
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03/18/2026 - Federal Register Notice: Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026
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12/29/2025 - Federal Register Notice: Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
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12/11/2025 - FDA posts proposed administrative order (OTC000039)
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter
Human Use in response to an OTC Monograph Order Request (OMOR)
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09/02/2025 - FDA Posts the Fifth Annual Monograph Forecast
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06/04/2025 - FDA posts proposed administrative order Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
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06/04/2025 - FDA posts proposed administrative order Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms
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02/13/2025 - FDA posts proposed administrative order to Post Catalogue of Historical Monograph Documents
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11/07/2024 - FDA posts proposed administrative order Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products for Over-the-Counter Human Use
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09/30/2024 - FDA posts the fourth Annual Forecast for Planned Monograph Activities
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08/07/2024 - FDA reopened the comment period for proposed order OTC000035, "Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use" until September 27, 2024. Additional information can be found at: https://dgs.fda.gov/omuf/ordersearch/order_otc000035
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07/30/2024 - Federal Register Notice: Over-The-Counter Monograph Drug User Fee Program - OTC Monograph Order Requests (OMORs) Fee Rates for Fiscal Year 2025
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07/24/2024 - FDA issues final guidance for industry Providing Over-the-Counter Monograph Submissions in Electronic Format
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06/14/2024 - FDA posts proposed administrative order Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
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09/29/2023 - FDA posts the third Annual Forecast for Planned Monograph Activities
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09/11/2023 - Federal Register Notice: Over-The-Counter Monograph Drug User Fee Program - OTC Monograph Order Requests (OMORs) Fee Rates for Fiscal Year 2024
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08/28/2023 - FDA announces public meeting on the recommendations for Over-the-Counter Monograph Drug User Fee Program (OMDUFA) taking place September 28, 2023. Visit the meeting page for additional details and to register.
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06/22/2023 - FDA issues draft guidance for industry "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act"
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05/02/2023 - FDA posts remaining final administrative orders as deemed by the CARES Act on OTC Monographs@FDA. FDA also posts a revision to final Administrative Order OTC000024 Over-the-Counter Monograph M001: Antacid Products for Over-the-Counter Human Use OTC Monographs@FDA website
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05/02/2023 - FDA posts remaining five final administrative orders as deemed by the CARES Act. FDA also posts a revision to Final Administrative order OTC000024 Over-the-Counter Monograph M001: Antacid Products for Over-the-Counter Human Use OTC Monograph Reform website
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04/12/2023 - FDA issues draft guidance for industry "Over-the-Counter Monograph Order Requests (OMORs): Format and Content"
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03/24/2023 - Federal Register Notice: Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023
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10/14/2022 - FDA posts six additional final administrative orders as deemed by the CARES Act on OTC Monographs@FDA
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10/03/2022 - FDA announces expansion of the CDR NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions
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09/30/2022 - FDA posts the second Annual Forecast for Planned Monograph Activities
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09/22/2022 - FDA issues draft guidance for industry "Providing Over-the-Counter Monograph Submissions in Electronic Format"
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04/04/2022 - FDA posts two additional final administrative orders as deemed by the CARES Act on OTC Monographs@FDA
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03/16/2022 - Federal Register Notice: Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022
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02/01/2022 - FDA posts draft guidance for industry "Formal Meetings Between FDA and Sponsors of Requests of Over-the-Counter Monograph Drugs"
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12/16/2021 - FDA posts five additional final administrative orders as deemed by the CARES Act on OTC Monographs@FDA
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11/23/2021 - FDA posts four additional final administrative orders as deemed by the CARES Act on OTC Monographs@FDA
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10/01/2021 - FDA posts three additional final administrative orders as deemed by the CARES Act on OTC Monographs@FDA
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09/24/2021 - FDA posts proposed administrative order for OTC sunscreen products Notice of Availability: Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use
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09/24/2021 - FDA posts additional final administrative orders as deemed by the CARES Act, including for OTC sunscreen drug products, on OTC Monographs@FDA
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09/20/2021 - FDA in Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs Notice of Availability: Final Administrative Orders for Over-the-Counter Monographs
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03/26/2021 - Federal Register Notice: Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021
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