FDA.reportPublic FDA data

Application 071709

Type
ANDA
Sponsor
DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMAZEPAMTEMAZEPAMCAPSULE;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A071709-001TEMAZEPAMTEMAZEPAM30MGCAPSULE / ORAL1988-09-29

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071709-001TEMAZEPAM30MGCAPSULE / ORAL1988-09-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071709-001TEMAZEPAM30MGCAPSULE / ORAL1988-09-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071709-001TEMAZEPAM30MGCAPSULE / ORAL1988-09-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071709-001TEMAZEPAM30MGCAPSULE / ORAL1988-09-29a50c72e98297…

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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemazepamTEMAZEPAMPreferred Pharmaceuticals Inc.cbe5bd6a-f36a-4557-82d8-ef4e49d310e92026-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepackac08a51c-6c54-40da-9626-a4c82f337a3a2026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepack5d83e474-0932-49ae-ad92-ca278cd5f1d52026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepack1c08d30d-7c27-a09a-5240-7050771d5cc72026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
TemazepamTEMAZEPAMMajor Pharmaceuticals2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d2026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMPD-Rx Pharmaceuticals, Inc.62379cd5-a314-43eb-a1ee-33997623bfa32026-08-10Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMAscend Laboratories, LLC8f54731f-c5b7-492c-acb0-444c5fbb70292026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
TemazepamTEMAZEPAMREMEDYREPACK INC.85919240-0bac-4ed9-97aa-f1aa29be7ffa2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Temazepam
generic name: TEMAZEPAM
RESTORILTEMAZEPAMSpecGx LLCbc56f7fd-1aaf-48ff-8aa7-d467e59e10152026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TEMAZEPAM
TEMAZEPAMTEMAZEPAMSpecGx LLCc9bc61b4-a579-4003-98da-b6f6e381c1502026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TEMAZEPAM
generic name: TEMAZEPAM
TemazepamTEMAZEPAMAphena Pharma Solutions - Tennessee, LLC4a2ab77d-8b80-7eb1-e063-6394a90a14692026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMPreferred Pharmaceuticals Inc.7e3fd8fe-fb8a-4577-b540-0e3fefe636272026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
TemazepamTEMAZEPAMAmerican Health Packaginga3f06243-fa03-4cbd-951a-144ec43dcdfd2025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepack4fe8192a-0f65-4958-8b6d-e87b9fae9eb52025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepackbbb6e233-dc6b-43a7-8203-d91421d899212025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepacka1f0ed55-9401-4afe-ba98-1ca115ba86b52025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMA-S Medication Solutions19b2711e-587a-47d2-ab62-d564e7b871952025-10-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMPD-Rx Pharmaceuticals, Inc.45ef5e9c-f381-48d3-895d-e1d29be856ac2025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMBryant Ranch Prepackdadc2f66-7fa5-4be4-a9d0-d96e5836f5502025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM
temazepamTEMAZEPAMAsclemed USA, Inc.254a0273-c0f3-4d2d-b18e-4ab51ba4bc502025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temazepam
generic name: TEMAZEPAM

Reported adverse events (FAERS/openFDA)#

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