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OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02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N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML)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 39 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Extra Strength ACETAMINOPHEN Chain Drug Marketing Association cfaf9495-e654-4dfc-ba23-d2358c3720c4 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN 8 Hour Pain Relief ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. 3ec966f5-bdcb-4bd8-b265-c776ba778f25 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN 8 Hour Arthritis Pain ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. 1ac7ed71-5afe-d09c-e063-6294a90a3b88 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN 8HR Muscle Aches and Pain ACETAMINOPHEN AAA Pharmaceutical, Inc. 15abb899-e301-40e6-e063-6294a90a4bac 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN 8HR Muscle Aches and Pain ACETAMINOPHEN FSA STORE INC. 13268603-0080-22cf-e063-6394a90a7db4 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC f1e940ef-3cf0-4a5c-8158-156d0e5a680d 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Trifecta Pharmaceuticals USA LLC 026bf664-d598-73de-e063-6394a90a9206 2024-06-12 Warnings Name fallback generic name: ACETAMINOPHEN Regular Strength Pain Relief ACETAMINOPHEN NuCare Pharmaceuticals,Inc. 7c73fc75-af9b-177c-e053-2a91aa0ada56 2024-06-12 Warnings Name fallback generic name: ACETAMINOPHEN pain and fever ACETAMINOPHEN Meijer Distribution Inc cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf 2024-06-07 Warnings Name fallback generic name: ACETAMINOPHEN acetaminophen for children ACETAMINOPHEN NuCare Pharmaceuticals,Inc. 5f86e792-3262-4ee6-e053-2991aa0a54a0 2024-06-06 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 033a6153-2651-4703-8a94-def461838113 2024-06-05 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN BluePoint Laboratories c065c531-88f5-0930-e053-2a95a90ae861 2024-06-05 Warnings Name fallback generic name: ACETAMINOPHEN CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 126ee71a-c408-415b-9a43-502337a91055 2024-06-05 Warnings Name fallback generic name: ACETAMINOPHEN Tylenol Extra Strength ACETAMINOPHEN A-S Medication Solutions 85294a70-3233-4ba5-bc36-ee3f2964aebf 2024-06-05 Warnings Name fallback generic name: ACETAMINOPHEN acetaminophen for children ACETAMINOPHEN NuCare Pharmaceutiacals,Inc. 5d7ef1d2-d970-7b01-e053-2991aa0a1311 2024-06-04 Warnings Name fallback generic name: ACETAMINOPHEN CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company 0a28a4f1-d947-489b-be28-36ba10b581cf 2024-06-01 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 77fb237f-28b5-486b-b9ef-cb324d5cc0bd 2024-05-30 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack b5053cf5-209d-4106-afc2-cf9af85f4a69 2024-05-29 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