FDA.reportPublic FDA data

Application 208314

Type
ANDA
Sponsor
AUROBINDO PHARMA 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
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

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 22:38:342026-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEAurohealth LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
ndc (product): 58602-702

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 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9603LoratadineLoratadineWALGREEN CO.ANDACurrent
0363-9603LoratadineLoratadineWALGREEN CO.ANDACurrent
30142-066LoratadineLoratadineKROGER COMPANYANDACurrent
30142-066LoratadineLoratadineKROGER COMPANYANDACurrent
50268-489LoratadineLoratadineAvPAKANDACurrent
50268-489LoratadineLoratadineAvPAKANDACurrent
50268-489LoratadineLoratadineAvPAKANDACurrent
57243-200LoratadineLoratadineMcLane Company, Inc.ANDACurrent
57243-200LoratadineLoratadineMcLane Company, Inc.ANDACurrent
57243-200LoratadineLoratadineMcLane Company, Inc.ANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-702LoratadineLoratadineAurohealth LLCANDACurrent
58602-831LoratadineLoratadineAurohealth LLCANDACurrent
58602-831LoratadineLoratadineAurohealth LLCANDACurrent
58602-831LoratadineLoratadineAurohealth LLCANDACurrent
58602-847LoratadineLoratadineAurohealth LLCANDACurrent
58602-847LoratadineLoratadineAurohealth LLCANDACurrent
58602-847LoratadineLoratadineAurohealth LLCANDACurrent
58602-847LoratadineLoratadineAurohealth LLCANDACurrent
67091-408LoratadineLoratadineWinco Foods, LLC.ANDACurrent
68001-438LoratadineLoratadineBluePoint LaboratoriesANDACurrent
68001-438LoratadineLoratadineBluePoint LaboratoriesANDACurrent
68001-438LoratadineLoratadineBluePoint LaboratoriesANDACurrent
68016-094LoratadineLoratadineChain Drug Consortium, LLCANDACurrent
68016-094LoratadineLoratadineChain Drug Consortium, LLCANDACurrent
68016-094LoratadineLoratadineChain Drug Consortium, LLCANDACurrent
68016-094LoratadineLoratadineChain Drug Consortium, LLCANDACurrent
68016-094LoratadineLoratadineChain Drug Consortium, LLCANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
69842-242LoratadineLoratadineCVS Pharmacy, Inc.ANDACurrent
70000-0583LoratadineLoratadineCardinal HealthANDACurrent
70000-0583LoratadineLoratadineCardinal HealthANDACurrent
73581-203ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent
73581-203ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent
73581-203ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent
73581-203ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent
73581-203ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent