Home Applications 201653 Application 201653
Type ANDA
Sponsor SUN PHARM INDS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL 5MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201653-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2015-06-26
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A201653-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2015-06-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201653-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2015-06-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201653-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2015-06-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 4 of 4 · 72 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Proficient Rx LP 7108ad0a-af1e-4172-b4ba-e5d9aaadfba7 2022-10-01 Warnings, Adverse reactions Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Proficient Rx LP 1ceff0e6-1e66-4494-b986-1bd23eb6813e 2022-03-01 Warnings, Adverse reactions Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE Topcare All Day Allergy LEVOCETIRIZINE DIHYDROCHLORIDE Topco Associates LLC 393616df-52f1-4e77-b69c-8239ca193d5b 2022-02-21 Warnings Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE DG Health Allergy Relief LEVOCETIRIZINE DIHYDROCHLORIDE Dolgencorp, LLC 470fee97-daab-4967-9c0e-77bacfb2ccd8 2021-06-24 Warnings Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Camber Consumer Care Inc be72dafb-62ae-40b2-874f-1d8920fad19d 2020-11-30 Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE basic care allergy relief LEVOCETIRIZINE DIHYDROCHLORIDE Amazon.com Services LLC fe965a15-7789-4ea5-b33e-2d3513409e1a 2020-11-02 Warnings Name fallback generic name: LEVOCETIRIZINE DIHYDROCHLORIDE Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Proficient Rx LP f10cfe9a-1884-4a65-b827-8fd781fb75c4 2020-01-01 Warnings, Adverse reactions Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Proficient Rx LP b84ccb27-9c52-43b9-9a46-8f52a571045e 2019-11-01 Warnings, Adverse reactions Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Bryant Ranch Prepack 34541530-ae3b-4247-b08c-cd1c13e2e6a1 2019-06-11 Warnings, Adverse reactions Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Dr.Reddy's laboratories Ltd. c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a 2018-12-06 Warnings, Adverse reactions Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Vensun Pharmaceuticals, Inc. 7a2ca8aa-ba0b-45b4-bdb3-651879350130 2018-07-13 Warnings, Adverse reactions Name fallback brand name: levocetirizine dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE Marlex Pharmaceuticals Inc f5d8d6a6-6455-430b-8923-090e1ca2ae3b 2018-01-01 Warnings, Adverse reactions Name fallback brand name: Levocetirizine Dihydrochloride generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63304-433 Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride Ranbaxy Pharmaceuticals Inc. ANDA Current