FDA.reportPublic FDA data

Application 065094

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL150MGNoNo
002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065094-001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORAL2004-03-22
A065094-002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORAL2004-03-22

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A065094-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORAL2004-03-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065094-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORAL2004-03-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065094-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORAL2004-03-22e64feba35796…
2022-09-29 23:25 UTC2022-09A065094-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORAL2004-03-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065094-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORAL2004-03-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065094-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORAL2004-03-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065094-001DEMECLOCYCLINE HYDROCHLORIDE150MGTABLET / ORAL2004-03-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065094-002DEMECLOCYCLINE HYDROCHLORIDE300MGTABLET / ORAL2004-03-22a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Demeclocycline HydrochlorideDEMECLOCYCLINEAmneal Pharmaceuticals of New York LLC539add06-e0a0-401a-b4f6-20776084aa9c2026-04-02Warnings, Adverse reactionsName fallback
brand name: Demeclocycline Hydrochloride
Demeclocycline HydrochlorideDEMECLOCYCLINE HYDROCHLORIDEPuraCap Laboratories LLC88e03cb0-25f5-41a5-b77f-58ab8f3be1812025-12-11Warnings, Adverse reactionsName fallback
brand name: Demeclocycline Hydrochloride
generic name: DEMECLOCYCLINE HYDROCHLORIDE
Demeclocycline HydrochlorideDEMECLOCYCLINEAmneal Pharmaceuticals LLC4ff23e3b-e111-47fd-9776-1d89d6da049b2024-10-24Warnings, Adverse reactionsName fallback
brand name: Demeclocycline Hydrochloride
Demeclocycline HydrochlorideDEMECLOCYCLINEAmerican Health Packaginge6adaf70-5ff9-4395-bff1-0f332090cb802024-09-26Warnings, Adverse reactionsName fallback
brand name: Demeclocycline Hydrochloride
Demeclocycline HydrochlorideDEMECLOCYCLINE HYDROCHLORIDEEpic Pharma, LLC645af8f4-0843-4afb-9ddc-f587f38adb682023-11-08Warnings, Adverse reactionsName fallback
brand name: Demeclocycline Hydrochloride
generic name: DEMECLOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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