Application 072433

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001Q-PAMDIAZEPAMTABLET;ORAL10MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072433-001Q-PAMDIAZEPAM10MGTABLET / ORAL1988-04-29

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072433-001Q-PAM10MGTABLET / ORAL1988-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A072433-001Q-PAM10MGTABLET / ORAL1988-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072433-001Q-PAM10MGTABLET / ORAL1988-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A072433-001Q-PAM10MGTABLET / ORAL1988-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072433-001Q-PAM10MGTABLET / ORAL1988-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072433-001Q-PAM10MGTABLET / ORAL1988-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072433-001Q-PAM10MGTABLET / ORAL1988-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072433-001Q-PAM10MGTABLET / ORAL1988-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072433-001Q-PAM10MGTABLET / ORAL1988-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072433-001Q-PAM10MGTABLET / ORAL1988-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072433-001Q-PAM10MGTABLET / ORAL1988-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072433-001Q-PAM10MGTABLET / ORAL1988-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072433-001Q-PAM10MGTABLET / ORAL1988-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072433-001Q-PAM10MGTABLET / ORAL1988-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072433-001Q-PAM10MGTABLET / ORAL1988-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072433-001Q-PAM10MGTABLET / ORAL1988-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072433-001Q-PAM10MGTABLET / ORAL1988-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072433-001Q-PAM10MGTABLET / ORAL1988-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072433-001Q-PAM10MGTABLET / ORAL1988-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A072433-001Q-PAM10MGTABLET / ORAL1988-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072433-001Q-PAM10MGTABLET / ORAL1988-04-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-293f01610625f2…
2019-09-15 20:21 UTC2019-09A072433-001Q-PAM10MGTABLET / ORAL1988-04-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A072433-001Q-PAM10MGTABLET / ORAL1988-04-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072433-001Q-PAM10MGTABLET / ORAL1988-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072433-001Q-PAM10MGTABLET / ORAL1988-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072433-001Q-PAM10MGTABLET / ORAL1988-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072433-001Q-PAM10MGTABLET / ORAL1988-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072433-001Q-PAM10MGTABLET / ORAL1988-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072433-001Q-PAM10MGTABLET / ORAL1988-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072433-001Q-PAM10MGTABLET / ORAL1988-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A072433-001Q-PAM10MGTABLET / ORAL1988-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A072433-001Q-PAM10MGTABLET / ORAL1988-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072433-001Q-PAM10MGTABLET / ORAL1988-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072433-001Q-PAM10MGTABLET / ORAL1988-04-29f41ea6bd6efb…

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 2 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIAZEPAMDIAZEPAMHenry Schein, Inc.52fc91f4-992f-47cb-a7d2-b26d745774812026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMSafecor Health, LLC8b51f4b3-a5e8-4400-b624-ac0c47630c862026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMHenry Schein, Inc.bfa85a63-967f-4176-a752-0bafabbaaae32026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMNatco Pharma USA LLC6b8dc373-fa01-42c9-89af-4e00bf00180a2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMSagent Pharmaceuticals7a912f1a-deee-46df-a8df-22a0afb065292026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMDirect_Rx181cc7ac-5129-2200-e063-6394a90afd3a2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMLupin Pharmaceuticals,Inc.d99b68aa-b3dc-49c8-8894-3da255cd26b02025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
ValiumDIAZEPAMRoche Laboratories Inc.554baee5-b171-4452-a50a-41a0946f956c2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DIAZEPAMDIAZEPAMHenry Schein, Inc.dcf7bc20-6c57-491a-b9e3-f42bacff8b992025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DIAZEPAMDIAZEPAMASCLEMED USA INC.426f3da1-4105-ba0a-e063-6294a90a7a862025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMA-S Medication Solutions01f04ee4-fff9-499a-8213-984e163680842025-10-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.c2768add-5e01-4ff4-afa3-230380d59a1f2025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.1ad84940-40f7-457a-8ffa-53e1a7bfee162025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.2483426d-3782-432a-8b8d-86c06ef0de4a2025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.84cecab3-d0e6-436b-996b-0b598e9723082025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMNatco Pharma USA LLC19d0e3e5-f081-4574-9f0a-e7e97a88c7a92025-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMA-S Medication Solutionsec433be5-d84d-425f-9edf-71263f885eec2025-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM
DiazepamDIAZEPAMPrecision Dose Inc.78d5a77d-5ca7-4f16-b4d0-fce86456593c2025-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIAZEPAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.