FDA.reportPublic FDA data

Application 061802

Type
ANDA
Sponsor
ABBOTT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDECAPSULE;ORAL250MGNoNo
002TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDECAPSULE;ORAL500MGNoNo

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
A061802-001TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982
A061802-002TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982

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 UTC2022-10A061802-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A061802-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061802-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A061802-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061802-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061802-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061802-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061802-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982a50c72e98297…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack02e88b4a-57ae-4ef6-ba48-97c657202b942026-08-11Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc. .ccd30048-a226-455f-971b-5dbf14b22e9d2026-06-11Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.00acf413-c5d2-4a54-9d0d-56266cbc9edc2026-05-22Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack22208459-3e6f-46a7-9f7f-f2c254a381322026-05-12Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEProficient Rx LPd48071a0-c397-42f8-b8ad-158282e745e32026-05-01Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCb504e612-5aef-47fa-8f7b-dfb754011b9f2026-04-14Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3ce3e8dc-7fbd-4f8d-a65f-092e1ef217252025-11-06Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCae29aa18-6efb-47c9-bbd7-cbe8af1b7f382025-04-24Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEActavis Pharma, Inc.32a409a0-fea6-411a-8218-c1c7df46d6642025-04-09Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4202cbfb-52e9-47f2-bd3a-1003319ca3cb2025-03-24Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.eaa5b1bd-0927-46e4-b941-32fcc492d2582025-03-18Warnings, Adverse reactionsName fallback
brand name: tetracycline hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsName fallback
generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack58e4b5b3-e093-46e7-b28e-a2c4821c5b632024-11-12Warnings, Adverse reactionsName fallback
brand name: Tetracycline Hydrochloride
generic name: TETRACYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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