FDA.reportPublic FDA data

Application 078359

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESLORATADINEDESLORATADINETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078359-001DESLORATADINEDESLORATADINE5MGTABLET / ORAL2010-11-16

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078359-001DESLORATADINE5MGTABLET / ORAL2010-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078359-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078359-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078359-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078359-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078359-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078359-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078359-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078359-001AB1ea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesloratadineDESLORATADINEMorepen Bio Inc.21174c0f-9204-4c75-b6e6-2f9ada5b535d2026-08-26Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.2a90b899-7746-43dc-ac8a-e754428eb30c2026-06-30Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEBryant Ranch Prepackf84c8de3-a7d3-4e8b-bfb6-04259e79450a2026-06-01Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DesloratadineDESLORATADINENatco Pharma USA LLCe4db30a5-48e5-4fe3-8793-30b6866f87c12026-04-23Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutionsa3b61ab9-ec20-4831-b69a-fcd913fce5402026-04-16Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DESLORATADINEDESLORATADINEA-S Medication Solutions69b9635b-c790-4316-a790-67b0f5512b722026-04-16Warnings, Adverse reactionsName fallback
brand name: DESLORATADINE
generic name: DESLORATADINE
DesloratadineDESLORATADINEBryant Ranch Prepackcf7f838b-4595-4c81-97b9-e1594347e1bd2025-11-06Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
Desloratadine Oral SolutionDESLORATADINEINA Pharmaceutics, Inc.41d5e0d4-6188-847b-e063-6294a90a2e2f2025-10-23Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEVirtus Pharmaceuticals, LLC0fe374d0-c14b-4102-b568-eb79165fc7ef2025-07-10Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
ClarinexDESLORATADINEOrganon LLCc671342e-69a2-4ca5-abc2-8166ed4240d42025-05-17Warnings, Adverse reactionsName fallback
generic name: DESLORATADINE
DesloratadineDESLORATADINEDr. Reddy's Laboratories Limitede5d1f465-e436-b4fd-d351-07a7b2acb4402024-02-28Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DesloratadineDESLORATADINEA-S Medication Solutions36307c2b-6b6a-46a9-9fe4-1798fc72e7b82023-12-12Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE
DesloratadineDESLORATADINEBionpharma Inc.4d094001-b85a-47b3-bc67-a46660384ece2023-11-27Warnings, Adverse reactionsName fallback
brand name: Desloratadine
generic name: DESLORATADINE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-523DesloratadineDesloratadineSun Pharmaceutical Industries, Inc.ANDACurrent
62756-523DesloratadineDesloratadineSun Pharmaceutical Industries, Inc.ANDACurrent