Home Applications 213266 Application 213266
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE;ORAL EQ 2MG BASE No No 002 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE;ORAL EQ 4MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213266-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 A213266-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03
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 · 68 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 2026-08-18 06:07:40 2026-07 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213266-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213266-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2021-08-03 782e0a99824c…
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 · 8 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58602-835 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-835 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-835 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-836 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-836 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-836 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-903 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-904 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-905 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current 58602-906 NICOTINE NICOTINE POLACRILEX Aurohealth LLC ANDA Current