Home Applications 022450 Application 022450
Type NDA
Sponsor MALLINCKRODT HOSP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OFIRMEV ACETAMINOPHEN SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022450-001 OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022450-001 10383834 2028-11-13 U-2262 2019-09-18 N022450-001 10383834 2028-11-13 U-2621 2019-09-18 N022450-001 9610265 2028-11-13 U-2263 2017-05-04 N022450-001 9987238 2028-11-13 U-2261 2018-06-13 N022450-001 10383834*PED 2029-05-13 Pediatric extension N022450-001 9610265*PED 2029-05-13 Pediatric extension N022450-001 9987238*PED 2029-05-13 Pediatric extension N022450-001 9399012 2031-09-11 U-2261 2016-08-08 N022450-001 9399012 2031-09-11 U-2262 2016-08-08 N022450-001 9399012*PED 2032-03-11 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022450-001 OFIRMEV 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2010-11-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 406 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022450-001 10383834 2028-11-13 U-2262 2019-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 10383834 2028-11-13 U-2621 2019-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9610265 2028-11-13 U-2263 2017-05-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9987238 2028-11-13 U-2261 2018-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 10383834*PED 2029-05-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9610265*PED 2029-05-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9987238*PED 2029-05-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9399012 2031-09-11 U-2262 2016-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9399012 2031-09-11 U-2261 2016-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022450-001 9399012*PED 2032-03-11 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022450-001 10383834 2028-11-13 U-2262 2019-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 10383834 2028-11-13 U-2621 2019-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9610265 2028-11-13 U-2263 2017-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9987238 2028-11-13 U-2261 2018-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 10383834*PED 2029-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9610265*PED 2029-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9987238*PED 2029-05-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9399012 2031-09-11 U-2262 2016-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9399012 2031-09-11 U-2261 2016-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022450-001 9399012*PED 2032-03-11 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022450-001 10383834 2028-11-13 U-2262 2019-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 10383834 2028-11-13 U-2621 2019-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9610265 2028-11-13 U-2263 2017-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9987238 2028-11-13 U-2261 2018-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 10383834*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9610265*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9987238*PED 2029-05-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9399012 2031-09-11 U-2262 2016-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9399012 2031-09-11 U-2261 2016-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022450-001 9399012*PED 2032-03-11 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 10383834 2028-11-13 U-2262 2019-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 10383834 2028-11-13 U-2621 2019-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9610265 2028-11-13 U-2263 2017-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9987238 2028-11-13 U-2261 2018-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 10383834*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9610265*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9987238*PED 2029-05-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9399012 2031-09-11 U-2262 2016-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9399012 2031-09-11 U-2261 2016-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022450-001 9399012*PED 2032-03-11 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 46 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Reliever ACETAMINOPHEN Magno-Humphries, Inc. 9d22bedb-9fb3-8421-e053-2a95a90acf4a 2023-10-27 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Regular Strength ACETAMINOPHEN Magno-Humphries, Inc. 9d22d642-8aaf-d17e-e053-2995a90ae182 2023-10-27 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever ACETAMINOPHEN WALGREENS f3c69974-7f51-2227-e053-2995a90a5570 2023-10-21 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Pain Relief ACETAMINOPHEN Geri-Care Pharmaceutical Corp e65dbd01-2d5e-4067-ad98-98d879cfb5ee 2023-10-19 Warnings Name fallback generic name: ACETAMINOPHEN Regular Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. f06fe167-8a16-14d9-e053-2a95a90a1a0f 2023-10-17 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Chewable Acetaminophen ACETAMINOPHEN BLESSINGS INTERNATIONAL ee8ba190-2c42-7ca2-e053-2a95a90a01a0 2023-10-17 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Extended-Release Tablets, 650 mg ACETAMINOPHEN MARKSANS PHARMA LIMITED d973a910-5fe0-4a85-884d-2c3987836691 2023-10-17 Warnings Name fallback generic name: ACETAMINOPHEN Aphen ACETAMINOPHEN Asclemed USA, Inc. fe3c0a2b-316b-4620-b6bc-378dbaf7ed57 2023-10-16 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever Extra Strength ACETAMINOPHEN Walgreens b4b06d32-6a09-4c43-980b-377b617ba739 2023-10-09 Warnings Name fallback generic name: ACETAMINOPHEN childrens mapap ACETAMINOPHEN Proficient Rx LP 88c4183a-3032-46de-bf18-f700055f617b 2023-10-01 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC 852e70e2-7279-6f33-e053-2991aa0a8676 2023-08-28 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Eugia US LLC f80b6f72-f280-4b4a-a6a9-e6490b94705b 2023-08-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg ACETAMINOPHEN BENARD INDUSTRIES INC eaa9d094-ece6-41fd-97d9-0fdb0a45afd7 2023-06-19 Warnings Name fallback generic name: ACETAMINOPHEN Arthritis Pain ACETAMINOPHEN BETTER LIVING BRANDS, LLC ee84323a-b615-3ec6-e053-2995a90a5a26 2023-06-15 Warnings Name fallback generic name: ACETAMINOPHEN 8 Hour Pain Relief ACETAMINOPHEN STRATEGIC SOURCING SERVICES LLC c003a34a-bfe5-4298-8a4e-8c75576f5674 2023-06-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN B. Braun Medical Inc. 6d763554-913d-4bed-9efd-b9c9b936a2f4 2023-05-18 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN eight hour pain relief ACETAMINOPHEN United Natural Foods, Inc. dba UNFI b5fe8873-13c9-402e-b06c-6e679af7267e 2023-05-17 Warnings Name fallback generic name: ACETAMINOPHEN pain reliever fever reducer childrens ACETAMINOPHEN Walgreen Company f2085b26-5778-4656-8de3-9edd83f914dd 2023-05-03 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN WG Critical Care, LLC 60f0d5b2-cab4-4a7c-8b53-1526a0908a54 2023-05-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN 8 hr Arthritis Pain Relief ACETAMINOPHEN DOLGENCORP, INC. ea2eae7c-e9bd-534c-e053-2a95a90a26c8 2023-04-20 Warnings Name fallback generic name: ACETAMINOPHEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Products Inc. NDA Current 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Pro NDA Current 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Products Inc. NDA Current 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Products Inc. NDA Current 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Products Inc. NDA Current 43825-102 Ofirmev acetaminophen Mallinckrodt Hospital Products Inc. NDA Current 51662-1424 OFIRMEV (ACETAMINOPHEN) OFIRMEV (ACETAMINOPHEN) HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1424 OFIRMEV (ACETAMINOPHEN) OFIRMEV (ACETAMINOPHEN) HF Acquisition Co LLC, DBA HealthFirst NDA Current