Home Applications 208653 Application 208653
Type NDA
Sponsor KVK TECH INC Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 1 of 4 · 126 observed 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 2026-08-18 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208653-002 APADAZ 325MG;EQ 4.08MG BASE TABLET / ORAL RLD 2019-01-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208653-003 APADAZ 325MG;EQ 8.16MG BASE TABLET / ORAL RLD 2019-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208653-001 APADAZ 325MG;EQ 6.12MG BASE TABLET / ORAL RLD 2018-02-23 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 16 · 630 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2026-02-19 14:30 UTC 2026-02 N208653-003 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 8828978 2030-07-01 Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208653-003 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8748413 2030-07-01 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8828978 2030-07-01 Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 9132125 2030-07-01 U-2249 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 9549923 2030-07-01 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-001 8461137 2031-02-22 Drug substance, Drug product 2018-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8748413 2030-07-01 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8828978 2030-07-01 Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 9132125 2030-07-01 U-2249 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 9549923 2030-07-01 Drug substance, Drug product 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208653-002 8461137 2031-02-22 Drug substance, Drug product 2019-01-25 31067a03dcf5…
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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table 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