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OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02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N022450-001 OFIRMEV 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2010-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022450-001 OFIRMEV 1GM/100ML (10MG/ML)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 41 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Baxter Healthcare Corporation 0f67c1bd-915b-4681-88dd-22f5154a80b3 2024-05-06 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Basic Care Childrens Pain and Fever ACETAMINOPHEN Amazon.com Services LLC bf8bed5d-7dd4-492c-98ac-c36ff8be8f41 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Basic Care Childrens Pain and Fever ACETAMINOPHEN Amazon.com Services LLC 0c133707-a8b8-4105-82f3-e3855ec19617 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN leader infants pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader cfbb8553-f3ac-437d-8f63-caa93f257a77 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN good sense childrens pain and fever ACETAMINOPHEN L. Perrigo Company ab96395c-a19e-40d6-b37e-7f988026fc95 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN WALGREEN CO. c20d110a-ed5e-aed4-e053-2a95a90a4200 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Good Sense pain and fever ACETAMINOPHEN L. Perrigo Company 48833e6a-db42-42b8-aa75-07103a1482a2 2024-04-30 Warnings Name fallback generic name: ACETAMINOPHEN basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC aaa2b462-5ccf-43b0-9d71-71de74653a21 2024-04-29 Warnings Name fallback generic name: ACETAMINOPHEN dg health childrens pain and fever ACETAMINOPHEN Dolgencorp Inc 49b2ac72-86a3-4783-bf51-8c1a222e457e 2024-04-25 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Fresenius Kabi USA, LLC a0cece43-256e-4adc-92f8-11a0f473bb83 2024-04-24 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC dab1f9e6-3875-4d53-a417-c6a78274ee56 2024-04-23 Warnings Name fallback generic name: ACETAMINOPHEN Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Name fallback generic name: ACETAMINOPHEN 8 Hour Pain Relief ACETAMINOPHEN KROGER COMPANY 0fec5c67-8d5d-8e45-e063-6394a90a982a 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Name fallback generic name: ACETAMINOPHEN infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Name fallback generic name: ACETAMINOPHEN Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 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