Home Applications 203762 Application 203762
Type ANDA
Sponsor TORRENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LACTULOSE LACTULOSE SOLUTION;ORAL, RECTAL 10GM/15ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A203762-001 LACTULOSE LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203762-001 AA
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 · 42 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 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL AA 2015-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203762-001 LACTULOSE 10GM/15ML SOLUTION / ORAL, RECTAL 2015-03-27 e64feba35796…
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lactulose LACTULOSE APOZEAL PHARMACEUTICALS INC a8af7389-3699-4873-b05a-509af7e8eaab 2026-01-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203762 application number: ANDA203762
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 13668-574 Lactulose Lactulose Torrent Pharmaceuticals Limited ANDA Current 39328-541 Lactulose Lactulose Patrin Pharma ANDA Current