FDA.reportPublic FDA data

Application 076301

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076301-001LORATADINELORATADINE10MGTABLET / ORAL2004-06-25

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25cb3db0bc1861…

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 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
dg health allergy reliefLORATADINEDolgencorp Incdfc4b065-1980-48ec-9c3e-aaa4a42214d32026-07-02WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
allergy reliefLORATADINERite Aid Corporation5d58ed7a-e40b-417f-a216-5ec6721d361b2026-05-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEL. Perrigo Company80e8a6e8-0c5f-4065-9545-112e146d25ee2026-04-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.039f144b-891b-4ab0-e063-6394a90aa4c82026-02-26WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.775885f9-0580-4eca-94d8-44fce1dcdccd2026-02-26WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
allergy reliefLORATADINECVS Pharmacy0038bc38-c205-4d8d-ab78-1abbcd76829e2026-02-25WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Berkley and Jensen Allergy ReliefLORATADINEBJWCe981a0ef-08e9-4ac3-92a1-411217e0a2512026-02-16WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEMajor Pharmaceuticals60162446-4fa1-4ee3-ae20-19fadc2491ab2026-02-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Allergy ReliefLORATADINEKroger Companydac0b200-6b02-4c8a-b1dd-a4d5341dfb2d2026-02-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENCS HealthCare of KY, LLC dba Vangard Labsf3d05276-21bd-419d-8dba-07ce278d33752025-12-22WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
goodnow allergy reliefLORATADINEGobrands, Inc352a1268-7f44-417d-a46a-f0cc2e944a262025-11-15WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions0eade963-be64-4718-a370-7e78efb91fc42025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions6f82e0ab-2c01-4afb-8d0f-b0c06819d1b02025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions4cee60b6-b32b-47d0-aa00-a7ea1a7ed3cf2025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 207 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-9080LoratadineLoratadinePreferred Pharmaceuticals, Inc.ANDACurrent
69256-612Harris Teeter Allergy ReliefLoratadineHarris Teeter, LLCANDACurrent
69256-612Harris Teeter Allergy ReliefLoratadineHarris Teeter, LLCANDACurrent
69256-612Harris Teeter Allergy ReliefLoratadineHarris Teeter, LLCANDACurrent
70000-0213Leader Allergy ReliefLoratadineCardinal HealthANDACurrent
70000-0213Leader Allergy ReliefLoratadineCardinal HealthANDACurrent
70000-0213Leader Allergy ReliefLoratadineCardinal HealthANDACurrent
70000-0213Leader Allergy ReliefLoratadineCardinal Health 110, LLC. dba LeaderANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0135LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-0780allergyLoratadineREMEDYREPACK INC.ANDACurrent
70518-0780allergyLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1335LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1448allergyLoratadineREMEDYREPACK INC.ANDACurrent
70518-1448allergyLoratadineREMEDYREPACK INC.ANDACurrent
70518-1603LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-1603LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70518-3302LoratadineLoratadineREMEDYREPACK INC.ANDACurrent
70925-612Humana Pharmacy Allergy ReliefLoratadineHumana Pharmacy, Inc.ANDACurrent
70925-612Humana Pharmacy Allergy ReliefLoratadineHumana Pharmacy, Inc.ANDACurrent
70934-467LoratadineLoratadineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-467LoratadineLoratadineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71610-423LoratadineLoratadineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-553LoratadineLoratadineAphena Pharma Solutions - Tennessee, LLCANDACurrent
72288-612basic care allergy reliefLoratadineAmazon.com Services LLCANDACurrent
72288-612basic care allergy reliefLoratadineAmazon.com Services LLCANDACurrent
72288-612basic care allergy reliefLoratadineAmazon.com Services Inc.ANDACurrent
72288-612basic care allergy reliefLoratadineAmazon.com Services LLCANDACurrent
72288-612basic care allergy reliefLoratadineAmazon.com Services LLCANDACurrent
72559-005Curist Allergy ReliefLoratadineLittle Pharma, Inc.ANDACurrent
80159-103Picnic AntihistamineLoratadine30M One, Inc.ANDACurrent
81522-612caring mill allergy reliefLoratadineFSA Store Inc.ANDACurrent