FDA.reportPublic FDA data

Application 074203

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONETABLET;ORAL50MG;25MGNoNo
002ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONETABLET;ORAL100MG;25MGNoNo

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
A074203-001ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-10-31
A074203-002ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-10-31

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 UTC2022-10A074203-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-10-31f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A074203-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074203-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-10-31e64feba35796…
2022-09-29 23:25 UTC2022-09A074203-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-10-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074203-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-10-31cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074203-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-10-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074203-001ATENOLOL AND CHLORTHALIDONE50MG;25MGTABLET / ORAL1993-10-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074203-002ATENOLOL AND CHLORTHALIDONE100MG;25MGTABLET / ORAL1993-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074203-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074203-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074203-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074203-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074203-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074203-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074203-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074203-002AB1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEREMEDYREPACK INC.dfbd0160-f56a-41b9-a4ff-eb2df73b1e9b2026-08-27Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEPreferred Pharmaceuticals Inc.c58e12ad-d705-4643-91ac-ff079e9eb28e2026-07-16Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEPD-Rx Pharmaceuticals, Inc.78b374f8-0e16-4c15-85c1-16609ac3aca22025-10-20Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone
ATENOLOL AND CHLORTHALIDONEATENOLOL AND CHLORTHALIDONE TABLETMARLEX PHARMACEUTICALS, INCdb22ff31-52f6-9024-e053-2995a90af8b32025-09-22Warnings, Adverse reactionsName fallback
brand name: ATENOLOL AND CHLORTHALIDONE
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEANI Pharmaceuticals, Inc.33690cc7-fffc-4620-888d-7f6453fe58c12024-03-14Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEActavis Pharma, Inc.a6794dfa-adbb-491b-9d48-f89a44e866c52024-03-01Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone
Atenolol and ChlorthalidoneATENOLOL AND CHLORTHALIDONEUnichem Pharmaceuticals (USA), Inc.a85d28c1-e812-4c12-aa67-136bff3610e52024-01-16Warnings, Adverse reactionsName fallback
brand name: Atenolol and Chlorthalidone

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2063Atenolol and Chlorthalidoneatenolol and chlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-2064Atenolol and Chlorthalidoneatenolol and chlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
43353-985Atenolol and Chlorthalidoneatenolol and chlorthalidoneAphena Pharma Solutions - Tennessee, LLCANDACurrent