Home Applications 205746 Application 205746
Type ANDA
Sponsor WOCKHARDT BIO AG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACETAMINOPHEN ACETAMINOPHEN SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) No No
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 A205746-001 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205746-001 AP1
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.
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 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2023-04-18 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205746-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2023-04-18 a50c72e98297…
Observed Orange Book normalized TE 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 48 of 49 · 961 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extended-Release ACETAMINOPHEN Magno-Humphries, Inc. 9d22bedb-9fc9-8421-e053-2a95a90acf4a 2021-10-28 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Sandoz Inc 2884e523-5f12-48d6-98dc-3a80cde524f8 2021-08-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Westminster Pharmaceuticals, LLC ace5ebac-ec11-4c26-b1e3-954b450ee671 2021-05-04 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Nighttime Cold and Flu Relief ACETAMINOPHEN Allegiant Health b97126d7-847d-483e-b3d1-e2b61ab1743f 2020-11-11 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Sandoz Inc 3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce9 2020-05-14 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Aphena Pharma Solutions - Tennessee, LLC 89134c3e-ec5b-4a57-952a-98d6c6cff7c2 2019-02-26 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC 2569383a-4a05-4ddb-852e-b37e487ffcde 2018-12-17 Warnings Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN Clear Choice Regular Strength Pain Reliever ACETAMINOPHEN Athlete's Needs, Inc. d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 2018-12-11 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Walgreen Company a1cec332-5802-4684-8b7f-6cb98da40e8b 2018-08-15 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Velocity Pharma LLC bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50 2018-05-14 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Advance Pharmaceutical Inc. 3793a17e-13bf-4d27-b8fa-6753b760f820 2017-12-22 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Advance Pharmaceutical Inc. aba26f0a-94e4-4919-a3b0-033e3a9598ef 2017-12-22 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Advance Pharmaceutical Inc. 5c75dc7f-06ae-440e-90ed-d7753eaa786e 2017-12-22 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Acetaminophen ACETAMINOPHEN PuraCap Pharmaceutical LLC f3c57374-1408-4459-a4de-ad12c2fc6b61 2017-11-09 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC. 3f9c230b-e6ea-4786-992b-9c7204425209 2017-11-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Richmond Pharmaceuticals, Inc. cda8e158-01ac-4c08-826e-4a0c7278e805 2017-10-30 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Richmond Pharmaceuticals, Inc. a30388fa-0d85-4eb3-babd-228170ebe96d 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Richmond Pharmaceuticals, Inc. ad087586-67cd-4875-b0e6-3fba06ea0f65 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Chewable Acetaminophen Childrens ACETAMINOPHEN Richmond Pharmaceuticals, Inc. a5dd9031-a960-4a98-ab71-05b079183f1a 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Tukol Acetaminophen Fever Reducer Pain Reducer ACETAMINOPHEN Genomma Lab USA, Inc. 0540111a-fcde-492d-9ed5-bbd714b2acf0 2017-04-15 Warnings Name fallback generic name: ACETAMINOPHEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.