FDA.reportPublic FDA data

Application 077442

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGNoNo

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
A077442-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2005-09-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077442-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2005-09-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC3bf95c58-4fd9-4caa-a54f-2e61a5eacae82026-05-06WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESportpharm LLC3b5c81b7-7464-129f-e063-6294a90a48c02026-02-06WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0a2672f0-4e6f-48c9-8571-2d09f06253d72026-01-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 50090-5554
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals658b0fe8-d564-4f79-bbb2-939c518651b72024-06-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
12 Hour Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH0ec510e8-a8cf-474b-9da4-2ac5122d6b492024-05-20WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.4e98dd9f-4ab9-4d95-95b0-799ce217da702024-01-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 51660-204
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companye33d6ca8-7b3c-42ad-85d3-3302a949501e2022-05-18WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 0363-0204
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH 110, LLC DBA LEADERa2189d7d-9335-4e96-8f6d-95c583739ac02022-05-12WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 70000-0601
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger Company00a8327b-41f0-4498-ad13-331256b539f92021-04-13WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 30142-967
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC918b2a90-532b-4358-bdff-9ad48c167a7e2020-08-11WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 62011-0306
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services53acd8d9-b9d8-4a38-8597-32043548d8322020-07-01WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 70677-0001
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEHEBd9b46ff2-8bde-47c0-bc63-b19dbe7e197b2019-05-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 37808-007
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.f398ceab-e3d2-421d-813e-b66369f654722019-05-01WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 51660-492
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy3a3d11e5-ebbf-4356-8ae6-4e5656b5644c2019-04-10WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 59779-204
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Consortium, LLCaec6412a-b62c-44c8-84f5-77f5fa4410282019-04-10WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 68016-204
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESAM'S WEST INC5a885a10-7751-44f1-b2d9-a918f27604df2019-03-29WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 68196-204
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEDISCOUNT DRUG MART7668ad20-1ca7-4d93-b3a3-03cfde141f862019-03-19WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 53943-204
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESafeway Inc.01a5d9dd-f123-443b-b968-412c0aadaaa22019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 21130-204
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Marketing Association Inc.880d368f-0ce3-4993-b5b1-13bf013105162019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 63868-143
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc9a6ece8b-7036-4cad-aeb3-993ef4bf614f2019-03-14WarningsExact identifier
application applno (ANDA): 077442
application number: ANDA077442
ndc (product): 56062-204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0904-5803SudoGestPseudoephedrine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-5803SudoGestPseudoephedrine HydrochlorideMajor PharmaceuticalsANDACurrent
21130-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideSafeway Inc.ANDACurrent
30142-967Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger CompanyANDACurrent
37012-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideShopko Stores Operating Co., LLCANDACurrent
37808-007Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideHEBANDACurrent
37808-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideHEBANDACurrent
41250-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideMeijer Distribution, Inc.ANDACurrent
46122-166Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideAmerisource BergenANDACurrent
46122-166Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideAmerisource BergenANDACurrent
46122-166Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideAmerisource BergenANDACurrent
50090-5554Pseudoephedrine hydrochloridePseudoephedrine hydrochlorideA-S Medication SolutionsANDACurrent
51660-204Pseudoephedrine hydrochloridePseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-492Pseudoephedrine hydrochloridepseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-492Pseudoephedrine hydrochloridepseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
53943-204Pseudoephedrine hydrochloridePseudoephedrine hydrochlorideDISCOUNT DRUG MARTANDACurrent
56062-204Pseudoephedrine HydrochloridePseudoephedrine HydrochloridePublix Super Markets IncANDACurrent
59779-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideCVS PharmacyANDACurrent
59779-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideCVS PharmacyANDACurrent
62011-0306Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideMckessonANDACurrent
62011-0306Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideSTRATEGIC SOURCING SERVICES LLCANDACurrent
63868-143Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
68016-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideChain Drug Consortium, LLANDACurrent
68016-204Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideChain Drug Consortium, LLCANDACurrent
68196-204Pseudoephedrine hydrochloridePseudoephedrine hydrochlorideSAM'S WEST INCANDACurrent
70000-0164Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideCardinal HealthANDACurrent
70000-0601Pseudoephedrine HydrochloridePseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC DBA LEADERANDACurrent
70518-3405Pseudoephedrine hydrochloridePseudoephedrine hydrochlorideREMEDYREPACK INC.ANDACurrent
70677-0001nasal decongestantPseudoephedrine HydrochlorideMCKESSON CORPORATIONANDACurrent
70677-0001nasal decongestantPseudoephedrine HydrochlorideStrategic Sourcing ServicesANDACurrent