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OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02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N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML)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 38 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join equate pain and fever infants ACETAMINOPHEN Wal-Mart Stores Inc 8a152c8d-8ae0-4201-8bb9-7b22c3577415 2024-07-10 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Name fallback generic name: ACETAMINOPHEN topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC a1145ac3-3e55-4bd5-a53e-6cf869add9a1 2024-07-02 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 4fb4f4b2-c238-4933-b874-08def3b34a28 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN good neighbor pharmacy pain and fever childrens ACETAMINOPHEN Amerisource Bergen ca0833ef-837b-47dc-8676-e016af96622c 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 4a030c3e-8104-4a0a-98c5-6ab469451f20 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Acetaminophen ACETAMINOPHEN Padagis Israel Pharmaceuticals Ltd a426dd82-b2d6-405e-b0af-cfb1310a6e19 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever ACETAMINOPHEN WALMART INC. (see also Equate) 7d86a03f-74f4-4b24-b6a6-8747acfe905e 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 5bcc5da9-7e64-4308-a5be-2f47a8ca774d 2024-06-25 Warnings Name fallback generic name: ACETAMINOPHEN pain relief ACETAMINOPHEN Meijer Distribution Inc 43c3fe72-a4ef-48a6-bc22-a644919c0c5c 2024-06-17 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN RETAIL BUSINESS SERVICES , LLC. 09315a3d-bb2d-4f06-e063-6294a90a3bd3 2024-06-14 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. 872365ca-0c6b-550a-e053-2a91aa0ab25a 2024-06-14 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Regular Strength ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION INC 613bc633-0426-41a7-aea9-9ff56311b607 2024-06-13 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