Application 206142
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;5MG | TABLET / ORAL | 2016-11-14 | ||
| A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;7.5MG | TABLET / ORAL | 2016-11-14 | ||
| A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 300MG;10MG | TABLET / ORAL | 2016-11-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2016-11-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2016-11-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2016-11-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2016-11-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2016-11-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2016-11-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2016-11-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2016-11-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | 2016-11-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | 2016-11-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | 2016-11-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;10MG | TABLET / ORAL | AA | 2016-11-14 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206142-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;5MG | TABLET / ORAL | AA | 2016-11-14 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206142-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 300MG;7.5MG | TABLET / ORAL | AA | 2016-11-14 | c0c555d07b60… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206142-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206142-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206142-003 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206142-003 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206142-003 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-002 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206142-003 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-002 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206142-003 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-002 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206142-003 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-002 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206142-003 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206142-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206142-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206142-003 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206142-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206142-002 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206142-003 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206142-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206142-002 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206142-003 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206142-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206142-002 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206142-003 | AA | 1 | ea99ee380514… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206142-001 | AA | 1 | a72a2bbeb626… |
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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 48cc1378-ffab-4645-95bb-a05d78066575 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 206142 ANDA206142 43386-353 43386-351 43386-352 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-351 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 40032-351 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 40032-352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 40032-352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 40032-353 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 40032-353 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Novel Laboratories, Inc. | ANDA | Current |
| 43386-351 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-351 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-351 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-353 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-353 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-353 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Lupin Pharmaceuticals,Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76132 | ORIG | 2023-11-03 |