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 29 of 51 · 1,003 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Acetaminophen ACETAMINOPHEN Geri-Care Pharmaceutical Corp 27fcca07-f845-77fe-e063-6394a90aa2f8 2025-04-24 Warnings Name fallback generic name: ACETAMINOPHEN acetaminophen ACETAMINOPHEN A-S Medication Solutions 46a6bbb9-ccd1-47a8-9e58-485f71f57063 2025-04-24 Warnings Name fallback brand name: acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN A-S Medication Solutions 061c91d5-5aa8-4556-a344-197b7e8a10b8 2025-04-24 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN A-S Medication Solutions c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 2025-04-24 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Extra Strength No-Pain ACETAMINOPHEN Safrel Pharmaceuticals, LLC. 873f01dd-0701-5fd3-e053-2a95a90a6463 2025-04-23 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever ACETAMINOPHEN Chain Drug Consortium 60d4b392-6ed0-4115-8154-24eaf72504a5 2025-04-16 Warnings Name fallback generic name: ACETAMINOPHEN foster and thrive pain reliever ACETAMINOPHEN Strategic Sourcing Services LLC 23780dab-91d8-434f-9342-f5f1ba0a3c0a 2025-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Vicks PainQuil PAIN RELIEVER ACETAMINOPHEN The Procter & Gamble Manufacturing Company 32841eaa-87ce-5f23-e063-6294a90a9118 2025-04-11 Warnings Name fallback generic name: ACETAMINOPHEN Foster and Thrive Pain Reliever ACETAMINOPHEN Strategic Sourcing Services LLC 0a7d82f8-7615-4cef-b245-94b186f3c8fa 2025-04-07 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Gland Pharma Limited db5d4cf8-762a-4111-971e-91c704bc3643 2025-04-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Name fallback brand name: Acetaminophen ACETAMINOPHEN ACETAMINOPHEN Granules Pharmaceuticals Inc. d5d49146-665e-4a93-e053-2995a90aca59 2025-04-02 Warnings Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Name fallback generic name: ACETAMINOPHEN Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Name fallback generic name: ACETAMINOPHEN CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Name fallback generic name: ACETAMINOPHEN 8HR Arthritis Pain ACETAMINOPHEN FSA STORE INC. 06446e9a-0e83-0623-e063-6294a90ac403 2025-03-07 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Name fallback generic name: ACETAMINOPHEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.