Application 076200
- Type
- ANDA
- Sponsor
- OHM LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN | ACETAMINOPHEN | TABLET, EXTENDED RELEASE;ORAL | 650MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076200-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076200-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2002-03-19 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Medline Industries, LP | 9f18d455-55ce-482c-8da8-dcb664038c6c | 2026-04-10 | Warnings | 076200 ANDA076200 53329-643 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0334 | Acetaminophen | Acetaminophen | Walgreen Company | ANDA | Current |
| 0363-0336 | Acetaminophen | Acetaminophen | Walgreen Company | ANDA | Current |
| 0363-0336 | Acetaminophen | Acetaminophen | Walgreen Company | ANDA | Current |
| 0363-0336 | Acetaminophen | Acetaminophen | Walgreen Company | ANDA | Current |
| 0615-8404 | Arthritis Pain Reliever | Acetaminophen | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8404 | Arthritis Pain Reliever | Acetaminophen | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8404 | Arthritis Pain Reliever | Acetaminophen | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 15127-332 | Acetaminophen | Acetaminophen | Select Brand | ANDA | Current |
| 21130-336 | Arthritis 8 Hour | Acetaminophen | Safeway Inc. | ANDA | Current |
| 21130-760 | Acetaminophen | Acetaminophen | Safeway Inc. | ANDA | Current |
| 21130-760 | Acetaminophen | Acetaminophen | Safeway Inc. | ANDA | Current |
| 30142-968 | Acetaminophen | ACETAMINOPHEN | The Kroger Company | ANDA | Current |
| 30142-968 | Acetaminophen | ACETAMINOPHEN | The Kroger Company | ANDA | Current |
| 30142-968 | Acetaminophen | ACETAMINOPHEN | The Kroger Company | ANDA | Current |
| 30142-970 | Arthritis Pain Reliever | Acetaminophen | The Kroger Company | ANDA | Current |
| 33261-665 | Arthritis Pain Reliever | Acetaminophen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 36800-228 | Topco Arthritis 8 Hour | Acetaminophen | Topco Associates LLC | ANDA | Current |
| 37012-333 | Acetaminophen | Acetaminophen | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-034 | Leader Arthritis Pain Reliever | Acetaminophen | Cardinal Health | ANDA | Current |
| 37205-477 | Leader 8 Hour Pain Reliever | Acetaminophen | Cardinal Health | ANDA | Current |
| 37808-333 | Acetaminophen | Acetaminophen | H-E-B | ANDA | Current |
| 41163-333 | Acetaminophen | Acetaminophen | SUPERVALU INC. | ANDA | Current |
| 41163-336 | Acetaminophen 8 Hour | Acetaminophen | Supervalu Inc. | ANDA | Current |
| 41520-333 | Acetaminophen | Acetaminophen | American Sales Company | ANDA | Current |
| 41520-336 | Acetaminophen-APAP 8 Hour | Acetaminophen | American Sales Company | ANDA | Current |
| 46122-062 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-062 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-062 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-062 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-062 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-170 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 46122-170 | Acetaminophen | Acetaminophen | Amerisource Bergen | ANDA | Current |
| 49348-921 | Sunmark Arthritis Pain Reliever | Acetaminophen | Sunmark | ANDA | Current |
| 49348-924 | Sunmark Arthritis 8 Hour | Acetaminophen | Sunmark | ANDA | Current |
| 49614-473 | Medicine Shoppe Arthritis Pain Reliever | Acetaminophen | The Medicine Shoppe International | ANDA | Current |
| 50268-052 | Arthritis Pain Reliever | Acetaminophen | AvPAK | ANDA | Current |
| 50268-052 | Arthritis Pain Reliever | Acetaminophen | AvPAK | ANDA | Current |
| 50268-052 | Arthritis Pain Reliever | Acetaminophen | AvPAK | ANDA | Current |
| 51660-333 | Arthritis Pain Reliever | Acetaminophen | Ohm Laboratories Inc. | ANDA | Current |
| 51660-333 | Arthritis Pain Reliever | Acetaminophen | Ohm Laboratories Inc. | ANDA | Current |
| 51660-333 | Arthritis Pain Reliever | Acetaminophen | Ohm Laboratories Inc. | ANDA | Current |
| 51660-333 | Arthritis Pain Reliever | Acetaminophen | Ohm Laboratories Inc. | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, Inc. | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, Inc. | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, Inc. | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, Inc. | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, LP | ANDA | Current |
| 53329-643 | Acetaminophen | Acetaminophen | Medline Industries, LP | ANDA | Current |
| 55315-333 | Acetaminophen | Acetaminophen | Fred's Inc. | ANDA | Current |
| 55315-333 | Acetaminophen | Acetaminophen | Fred's Inc. | ANDA | Current |
| 55319-333 | Acetaminophen | Acetaminophen | Family Dollar Services, Inc. | ANDA | Current |
| 55319-333 | Acetaminophen | Acetaminophen | Family Dollar Services, Inc. | ANDA | Current |
| 55319-333 | Acetaminophen | Acetaminophen | Family Dollar Services, Inc. | ANDA | Current |
| 55319-333 | Acetaminophen | Acetaminophen | Family Dollar Services, Inc. | ANDA | Current |
| 55319-333 | Acetaminophen | Acetaminophen | Family Dollar Services, I | ANDA | Current |
| 55700-679 | Arthritis Pain Reliever | Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-679 | Arthritis Pain Reliever | Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-679 | Arthritis Pain Reliever | Acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 59779-336 | Acetaminophen 8 Hour | Acetaminophen | CVS Pharmacy | ANDA | Current |
| 59779-350 | Acetaminophen | Acetaminophen | CVS Pharmacy | ANDA | Current |
| 59779-350 | Acetaminophen | Acetaminophen | CVS Pharmacy | ANDA | Current |
| 61919-860 | ACETAMINOPHEN | ACETAMINOPHEN | DirectRX | ANDA | Current |
| 62011-0026 | Acetaminophen | Acetaminophen | Health Mart | ANDA | Current |
| 63868-089 | Acetaminophen | Acetaminophen | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63868-089 | Acetaminophen | Acetaminophen | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63868-091 | Acetaminophen | Acetaminophen | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63868-091 | Acetaminophen | Acetaminophen | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63941-333 | Acetaminophen - APAP Arthritis | Acetaminophen | Valu Merchandisers Company | ANDA | Current |
| 63941-333 | Acetaminophen - APAP Arthritis | Acetaminophen | Valu Merchandisers Company | ANDA | Current |
| 63941-336 | Acetaminophen - APAP 8 Hour | Acetaminophen | Valu Merchandisers Company | ANDA | Current |
| 63941-336 | Acetaminophen - APAP 8 Hour | Acetaminophen | Valu Merchandisers Company | ANDA | Current |
| 66336-233 | Arthritis Pain Reliever | Acetaminophen | Dispensing Solutions, Inc. | ANDA | Current |
| 68016-333 | Premier Value Arthritis Pain Reliever | Acetaminophen | Chain Drug Consortium, LLC. | ANDA | Current |
| 68016-333 | Premier Value Arthritis Pain Reliever | Acetaminophen | Chain Drug Consortium, LLC. | ANDA | Current |
| 68016-336 | Premier Value Arthritis 8 Hour | Acetaminophen | Premier Value | ANDA | Current |
| 68016-336 | Premier Value Arthritis 8 Hour | Acetaminophen | Premier Value | ANDA | Current |
| 68071-1552 | Arthritis Pain Reliever | Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1552 | Arthritis Pain Reliever | Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1552 | Arthritis Pain Reliever | Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-777 | Arthritis Pain Reliever | Acetaminophen | American Health Packaging | ANDA | Current |