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 46 of 49 · 961 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Sense Childrens Pain and Fever ACETAMINOPHEN Proficient Rx LP 46527b1f-7515-44ce-b5cb-9d24223b9af1 2023-11-01 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN B. Braun Medical Inc. 9744d804-2857-47ef-a27a-bca27db9394c 2023-11-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN 8 Hour Arthritis Pain ACETAMINOPHEN AMERISOURCE BERGEN 7888eff3-3030-4aa0-89e3-9795aa214659 2023-10-31 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN AMERIFOODS TRADING COMPANY f6dd387d-c768-9443-e053-6394a90aca14 2023-10-31 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN SafeTynadol ACETAMINOPHEN Sinew Pharma Inc. b956d527-7ea7-e084-e053-2a95a90a866d 2023-10-28 Warnings Name fallback generic name: ACETAMINOPHEN 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 brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Eugia US LLC f80b6f72-f280-4b4a-a6a9-e6490b94705b 2023-08-03 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Acetaminophen 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.