FDA.reportPublic FDA data

Application 077153

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINE REDIDOSELORATADINETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo

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
A077153-001LORATADINE REDIDOSELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11

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 UTC2022-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEOhm Laboratories Inc.de3a7725-5d1b-4195-a9f8-43f92888997c2021-04-06WarningsExact identifier
application applno (ANDA): 077153
application number: ANDA077153
ndc (product): 51660-527

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0527LoratadineLoratadineWalgreen CompanyANDACurrent
0904-5806Loratadine ODTLoratadineMajor PharmaceuticalsANDACurrent
11673-513LoratadineLoratadineTarget CorporationANDACurrent
11673-527LoratadineLoratadineTarget CorporationANDACurrent
15127-979LoratadineLoratadineSelect BrandANDACurrent
21130-527Loratadine ODTLoratadineSafeway Inc.ANDACurrent
24385-161LoratadineLoratadineGood Neighbor PharmacyANDACurrent
24385-540LoratadineLoratadineGood Neighbor PharmacyANDACurrent
36800-527LoratadineLoratadineTopcare Associates LLCANDACurrent
36800-528Loratadine ODTLoratadineTopco Associates LLCANDACurrent
37012-527Loratadine ODTLoratadineShopko Stores Operating Co., LLCANDACurrent
37205-745Allergy ReliefLoratadineCardinal HealthANDACurrent
41163-528LoratadineLoratadineSupervalu Inc.ANDACurrent
41250-513Loratadine ODTLoratadineMeijer Distribution, Inc.ANDACurrent
41250-527Loratadine ODTLoratadineMeijer Distribution, Inc.ANDACurrent
41520-513LoratadineLoratadineAmerican Sales CompanyANDACurrent
41520-525LoratadineLoratadineAmerican Sales CompanyANDACurrent
41520-527LoratadineLoratadineAmerican Sales CompanyANDACurrent
46122-140LoratadineLoratadineGood Neighbor PharmacyANDACurrent
49348-929Sunmark Loratadine ODTLoratadineSunmarkANDACurrent
49348-930Sunmark Loratadine ODTLoratadineSunmarkANDACurrent
51660-527Allergy ReliefLoratadineOhm Laboratories Inc.ANDACurrent
51660-527Allergy ReliefLoratadineOhm Laboratories Inc.ANDACurrent
52904-430Allergy Relief Non DrowsyLoratadineSelect CorporationANDACurrent
55315-529Loratadine ODLoratadineFred's Inc.ANDACurrent
59779-527Loratadine ODTLoratadineCVS PharmacyANDACurrent
62011-0073HealthMart Loratadine ODTLoratadineHealth MartANDACurrent
63868-157LoratadineLoratadineChain Drug Marketing Association Inc.ANDACurrent
63941-528LoratadineLoratadineValu Merchandisers CompanyANDACurrent
68016-527Loratadine ODTLoratadineChain Drug Consortium, LLCANDACurrent