Application 203646

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGNoNo

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
A203646-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203646-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203646-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORALAB2014-09-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203646-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203646-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203646-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203646-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203646-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203646-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203646-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203646-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203646-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203646-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203646-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203646-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203646-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203646-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203646-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203646-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203646-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203646-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203646-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203646-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203646-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203646-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203646-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203646-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203646-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203646-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203646-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203646-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203646-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203646-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203646-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203646-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203646-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203646-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203646-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203646-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203646-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203646-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203646-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203646-001AB1cb3db0bc1861…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack8274ca80-e7d3-4f4f-9901-cc5c589b4fef2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 71335-1952
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackbe58ca52-ab5d-4656-bfe0-bd57662359682026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackc79d3668-5243-4627-ad2b-cc7c045df1202026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals,Inc.c2dbf151-5b3d-5dfb-e053-2995a90a4c192026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 68071-2406
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCdae403cd-b6fc-7c50-e053-2995a90a95e32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEGolden State Medical Supply, Inc.163dcce7-4535-a596-e063-6394a90a634f2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEScieGen Pharmaceuticals, Inc.bd7fe481-dfe7-4dfd-aa05-6e2318a9234e2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 50228-136
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWestminster Pharmaceuticals, LLC85dcd6c0-7fb2-40b3-b07f-93bab169011d2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 69367-238
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPreferred Pharmaceuticals, Inc.8f308352-5854-409e-8bf7-bc9958cc3c5e2025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 68788-7934
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs51d88b2a-d10d-4e7a-b874-98de480692232025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack4d0a0f8e-b298-46d2-b27d-0bb737507fed2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 63629-8500
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LP7108ad0a-af1e-4172-b4ba-e5d9aaadfba72022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 71205-476
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LP1ceff0e6-1e66-4494-b986-1bd23eb6813e2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 71205-988
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LPb84ccb27-9c52-43b9-9a46-8f52a571045e2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 63187-663
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack34541530-ae3b-4247-b08c-cd1c13e2e6a12019-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 71335-0940
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEVensun Pharmaceuticals, Inc.7a2ca8aa-ba0b-45b4-bdb3-6518793501302018-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203646
application number: ANDA203646
ndc (product): 42543-712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-386Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideAvKARE, Inc.ANDACurrent
42291-386Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideAvKARE, Inc.ANDACurrent
42291-386Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideAvKARE, Inc.ANDACurrent
42543-712levocetirizine dihydrochloridelevocetirizine dihydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
50228-136levocetirizine dihydrochloridelevocetirizine dihydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-136levocetirizine dihydrochloridelevocetirizine dihydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-136levocetirizine dihydrochloridelevocetirizine dihydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
61442-460Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCarlsbad Technology, Inc.ANDACurrent
63187-663levocetirizine dihydrochloridelevocetirizine dihydrochlorideProficient Rx LPANDACurrent
63187-663levocetirizine dihydrochloridelevocetirizine dihydrochlorideProficient Rx LPANDACurrent
63629-8500levocetirizine dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
63629-8500levocetirizine dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
68071-2406levocetirizine dihydrochloridelevocetirizine dihydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7934levocetirizine dihydrochloridelevocetirizine dihydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7934levocetirizine dihydrochloridelevocetirizine dihydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69117-1000Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideYILING PHARMACEUTICAL, INC.ANDACurrent
69117-1000Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideYILING PHARMACEUTICAL, INC.ANDACurrent
69367-238Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideWestminster PharmaceuticalsANDACurrent
70518-3366levocetirizine dihydrochloridelevocetirizine dihydrochlorideREMEDYREPACK INC.ANDACurrent
70934-400Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-835levocetirizine dihydrochloridelevocetirizine dihydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-476Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-476Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-988Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-988Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-988Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71335-0940levocetirizine dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
71335-0940levocetirizine dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
71335-1952levocetirizine dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent