FDA.reportPublic FDA data

Application 076134

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18f41ea6bd6efb…

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEValu Merchandisers Company0cd920b4-b15a-4ca9-87e2-4dd523c6d1f82018-08-28WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
ndc (product): 63941-526
LoratadineLORATADINEChain Drug Marketing Association Inc.b4edf5b1-398d-405a-8a42-76044b31ebb72018-08-27WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
ndc (product): 63868-151
Loratadine Allergy ReliefLORATADINEHEB6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda2018-05-14WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
ndc (product): 37808-529
LoratadineLORATADINEPremier Value778a6979-ea47-4381-8c40-84b3c2325a7e2018-01-11WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
ndc (product): 68016-526
Loratadine Allergy ReliefLORATADINELIDL US, LLC11bc027c-d28d-45f0-a4cb-24a3834a69952018-01-09WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134

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 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8317LoratadineLoratadineKaiser Foundation HospitalsANDACurrent
0363-0522LoratadineLoratadineWalgreen CompanyANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
10135-763Loratadine Allergy ReliefLoratadineMarlex Pharmaceuticals, Inc.ANDACurrent
15127-715LoratadineLoratadineSelect BrandANDACurrent
21130-526LoratadineLoratadineSAFEWAY INC.ANDACurrent
21130-526LoratadineLoratadineSAFEWAY INC.ANDACurrent
37012-526LoratadineLoratadineShopko Stores Operating Co., LLCANDACurrent
37205-346LEADER LoratadineloratadineCardinal HealthANDACurrent
37808-529Loratadine Allergy ReliefLoratadineHEBANDACurrent
41163-526LoratadineLoratadineSUPERVALU INC.ANDACurrent
46122-158LoratadineLoratadineAmerisource BergenANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
49614-170Medicine Shoppe Loratadine Allergy ReliefLoratadineThe Medicine Shoppe InternationalANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
51655-027LoratadineLoratadineNorthwind Pharmaceuticals, LLCANDACurrent
51660-209LoratadineLoratadineOhm Laboratories Inc.ANDACurrent
51660-526Loratadine Allergy ReliefLoratadineOHM LABORATORIES INC.ANDACurrent
51660-526Loratadine Allergy ReliefLoratadineOHM LABORATORIES INC.ANDACurrent
53002-7490Loratadine Allergy ReliefLoratadineRPK Pharmaceuticals, Inc.ANDACurrent
53002-7490Loratadine Allergy ReliefLoratadineRPK Pharmaceuticals, Inc.ANDACurrent
53329-651LoratadineLoratadineMedline Industries, Inc.ANDACurrent
53943-975Loratadine Allergy ReliefLoratadineDISCOUNT DRUG MARTANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55315-528LoratadineLoratadineFred's Inc.ANDACurrent
55315-528LoratadineLoratadineFred's Inc.ANDACurrent
55319-526LoratadineLoratadineFamily Dollar Services, Inc.ANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
56062-526LoratadineLoratadinePublix Super Markets IncANDACurrent
56062-526LoratadineLoratadinePublix Super Markets IncANDACurrent
59564-251LoratadineLoratadineInnovative Manufacturing and Distribution Services, Inc.ANDACurrent
59779-528LoratadineLoratadineCVS PharmacyANDACurrent
59779-528LoratadineLoratadineCVS PharmacyANDACurrent
61715-017LoratadineLoratadineKinrayANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63868-151LoratadineLoratadineChain Drug Marketing Association Inc.ANDACurrent
63941-526LoratadineLoratadineValu Merchandisers CompanyANDACurrent
64725-0526Loratadine Allergy ReliefLoratadineTYA PharmaceuticalsANDACurrent
67046-452Loratadine Allergy ReliefLoratadineContract Pharmacy Services-PAANDACurrent
67091-245Loratadine Allergy ReliefLoratadineWinCo Foods, LLCANDACurrent
67091-246Loratadine Allergy ReliefLoratadineWinCo Foods, LLCANDACurrent
67751-163Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.ANDACurrent
67751-163Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.ANDACurrent
68016-526LoratadineLoratadinePremier ValueANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43056ORIG2012-03-28
31084ORIG2003-04-16