Application 208653
- Type
- NDA
- Sponsor
- KVK TECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;EQ 6.12MG BASE | Yes | No |
| 002 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;EQ 4.08MG BASE | Yes | No |
| 003 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;EQ 8.16MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208653-001 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | |
| N208653-002 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | |
| N208653-003 | APADAZ | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208653-001 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | |
| N208653-001 | 8828978 | 2030-07-01 | Drug product | 2018-03-22 | |
| N208653-001 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2018-03-22 |
| N208653-001 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | |
| N208653-001 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2018-03-22 | |
| N208653-002 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | |
| N208653-002 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | |
| N208653-002 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 |
| N208653-002 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | |
| N208653-002 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | |
| N208653-003 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | |
| N208653-003 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | |
| N208653-003 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 |
| N208653-003 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | |
| N208653-003 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208653-002 | APADAZ | 325MG;EQ 4.08MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208653-003 | APADAZ | 325MG;EQ 8.16MG BASE | TABLET / ORAL | RLD | 2019-01-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208653-001 | APADAZ | 325MG;EQ 6.12MG BASE | TABLET / ORAL | RLD | 2018-02-23 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | 8828978 | 2030-07-01 | Drug product | 2018-03-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2018-03-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-001 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2018-03-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-002 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208653-003 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | 8828978 | 2030-07-01 | Drug product | 2018-03-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2018-03-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-001 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2018-03-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-002 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208653-003 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | 8828978 | 2030-07-01 | Drug product | 2018-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2018-03-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2018-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-001 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2018-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | 8748413 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | 8828978 | 2030-07-01 | Drug product | 2019-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | 9132125 | 2030-07-01 | U-2249 | Drug substance, Drug product | 2019-01-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | 9549923 | 2030-07-01 | Drug substance, Drug product | 2019-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208653-002 | 8461137 | 2031-02-22 | Drug substance, Drug product | 2019-01-25 | 011fe1cb6892… |
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 |
|---|---|---|---|---|---|---|
| APADAZ | BENZHYDROCODONE AND ACETAMINOPHEN | Zevra Therapeutics, Inc. | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 208653 NDA208653 70040-0189 70040-0145 70040-0167 |
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 |
|---|---|---|---|---|---|
| 10702-340 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-340 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-340 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-341 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-341 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-341 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-342 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-342 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-342 | APADAZ | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA | Current |
| 10702-343 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-343 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-343 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-343 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-344 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-344 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-344 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-344 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-345 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-345 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-345 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 10702-345 | Benzhydrocodone and Acetaminophen | Benzhydrocodone and Acetaminophen | KVK-Tech, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70040-0145 | APADAZ | Benzhydrocodone and Acetaminophen | KemPharm, Inc. | NDA | Current |
| 70040-0167 | APADAZ | Benzhydrocodone and Acetaminophen | KemPharm, Inc. | NDA | Current |
| 70040-0189 | APADAZ | Benzhydrocodone and Acetaminophen | KemPharm, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80098 | SUPPL | 2024-11-04 |
| 77058 | SUPPL | 2023-12-19 |
| 76991 | SUPPL | 2023-12-19 |
| 76963 | SUPPL | 2023-12-18 |
| 76247 | ORIG | 2023-11-03 |
| 66540 | SUPPL | 2021-03-05 |
| 66539 | SUPPL | 2021-03-05 |
| 66511 | SUPPL | 2021-03-05 |
| 60465 | SUPPL | 2019-10-09 |
| 60446 | SUPPL | 2019-10-09 |
| 60444 | SUPPL | 2019-10-09 |
| 57826 | ORIG | 2019-02-27 |
| 55712 | SUPPL | 2018-10-01 |
| 55711 | SUPPL | 2018-10-01 |
| 55519 | SUPPL | 2018-09-19 |
| 55518 | SUPPL | 2018-09-19 |
| 52722 | ORIG | 2018-02-26 |
| 52710 | ORIG | 2018-02-26 |