Home Applications 203690 Application 203690
Type ANDA
Sponsor PERRIGO R AND D 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 43 .
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 A203690-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 A203690-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203690-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203690-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2012-10-09 74a2ff9319b5…
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 5 · 84 matching rows.
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 2 · 146 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0734 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-0957 Good Sense Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-6000 Tru Relief Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-6001 Tru Relief Nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7007 basic care nicotine Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7008 basic care nicotine nicotine polacrilex L. Perrigo Company ANDA Current 0113-7201 Basic Care nicotine nicotine polacrilex L. Perrigo Company ANDA Current 0113-7203 Basic Care nicotine nicotine polacrilex L. Perrigo Company ANDA Current 0113-7734 basic care nicotine mini Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7734 basic care nicotine mini Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7957 basic care nicotine mini Nicotine Polacrilex L. Perrigo Company ANDA Current 0113-7957 basic care nicotine mini Nicotine Polacrilex L. Perrigo Company ANDA Current 0363-0734 nicotine mini Nicotine Polacrilex Walgreen Company ANDA Current 0363-0957 Nicotine mini Nicotine Polacrilex Walgreen Company ANDA Current 0363-1130 nicotine mini Nicotine Polacrilex Walgreen Company ANDA Current 0363-1130 nicotine mini Nicotine Polacrilex Walgreen Company ANDA Current 0363-1130 nicotine mini Nicotine Polacrilex Walgreen Company ANDA Current 0363-1825 nicotine nicotine polacrilex Walgreen Company ANDA Current 0363-1825 nicotine nicotine polacrilex Walgreen Company ANDA Current 0363-1825 nicotine nicotine polacrilex Walgreen Company ANDA Current 11673-734 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-734 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-734 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-734 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-858 up and up mini nicotine nicotine polacrilex Target Corporation ANDA Current 11673-879 up and up mini nicotine nicotine Target Corporation ANDA Current 11673-881 up and up mini nicotine polacrilex nicotine Target Corporation ANDA Current 11673-953 up and up mini nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-957 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-957 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-957 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11673-957 Up and Up Nicotine Nicotine Polacrilex Target Corporation ANDA Current 11822-0734 Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-0957 Mini Nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-1007 nicotine Nicotine Polacrilex Rite Aid Corporation ANDA Current 11822-3802 nicotine nicotine polacrilex Rite Aid Corporation ANDA Current 21130-172 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 21130-185 signature care nicotine Nicotine Polacrilex Safeway ANDA Current 30142-060 Nicotine Mini Nicotine Polacrilex Kroger Company ANDA Current 30142-060 Nicotine Mini Nicotine Polacrilex Kroger Company ANDA Current 30142-209 Nicotine Mini Nicotine Polacrilex Kroger Company ANDA Current 30142-209 Nicotine Mini Nicotine Polacrilex Kroger Company ANDA Current 30142-696 nicotine nicotine polacrilex Kroger Company ANDA Current 30142-797 nicotine nicotine polacrilex Kroger Company ANDA Current 30142-957 Nicotine Nicotine Polacrilex Kroger Company ANDA Current 36800-734 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-734 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-957 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 36800-957 Topcare Nicotine Nicotine Polacrilex Topco Associates LLC ANDA Current 37012-803 nicotine mini Nicotine Polacrilex Shopko Stores Operating Co., LLC ANDA Current 37012-957 nicotine mini Nicotine Polacrilex Shopko Stores Operating Co., LLC ANDA Current 37808-563 nicotine Nicotine Polacrilex H E B ANDA Current 37808-617 nicotine nicotine polacrilex H E B ANDA Current 37808-707 Nicotine nicotine H E B ANDA Current 37808-734 in control nicotine Nicotine Polacrilex H E B ANDA Current 37808-900 Nicotine nicotine H E B ANDA Current 37808-957 in control nicotine Nicotine Polacrilex H E B ANDA Current 41250-587 mini nicotine nicotine polacrilex Meijer Distribution Inc ANDA Current 41250-637 mini nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-734 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-734 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-957 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41250-957 Nicotine Nicotine Polacrilex Meijer Distribution Inc ANDA Current 41520-734 CareOne Nicotine Nicotine Polacrilex American Sales Company ANDA Current 41520-957 CareOne Mini Nicotine Polacrilex Nicotine Polacrilex American Sales Company ANDA Current 42884-734 Zonnic Nicotine Mini Nicotine Polacrilex Niconovum USA Inc. ANDA Current 42884-957 zonnic Nicotine Polacrilex Niconovum USA Inc. ANDA Current 45802-089 Nicotine Polacrilex Nicotine Polacrilex Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-089 Nicotine Polacrilex Nicotine Polacrilex Perrigo New York Inc ANDA Current 45802-957 Nicotine Polacrilex Nicotine Polacrilex Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-957 Nicotine Polacrilex Nicotine Polacrilex Perrigo New York Inc ANDA Current 46122-254 Good Neighbor Pharmacy Nicotine Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-255 good neighbor pharmacy nicotine mini Nicotine Polacrilex Amerisource Bergen ANDA Current 46122-663 good neighbor pharmacy nicotine nicotine polacrilex Amerisource Bergen ANDA Current 46122-665 good neighbor pharmacy nicotine mini Nicotine Polacrilex Amerisource Bergen ANDA Current 49035-734 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-734 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-734 Equate Nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-791 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current 49035-791 equate nicotine Nicotine Polacrilex Wal-Mart Stores Inc ANDA Current