Home Applications 203502 Application 203502
Type ANDA
Sponsor AUROLIFE PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET;ORAL 5MG No No 002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET;ORAL 10MG 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 A203502-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 A203502-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13107-088 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-088 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-088 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-088 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-088 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-089 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-089 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-089 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-089 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 13107-089 Methadone Hydrochloride Methadone Hydrochloride Aurolife Pharma, LLC ANDA Current 60687-214 Methadone Hydrochloride Methadone Hydrochloride American Health Packaging ANDA Current 60687-214 Methadone Hydrochloride Methadone Hydrochloride American Health Packaging ANDA Current 60687-214 Methadone Hydrochloride Methadone Hydrochloride American Health Packaging ANDA Current 60687-214 Methadone Hydrochloride Methadone Hydrochloride American Health Packaging ANDA Current 71335-0493 Methadone Hydrochloride Methadone Hydrochloride Bryant Ranch Prepack ANDA Current 71335-0493 Methadone Hydrochloride Methadone Hydrochloride Bryant Ranch Prepack ANDA Current 71335-0493 Methadone Hydrochloride Methadone Hydrochloride Bryant Ranch Prepack ANDA Current 71335-0735 Methadone Hydrochloride Methadone Hydrochloride Bryant Ranch Prepack ANDA Current 71335-0735 Methadone Hydrochloride Methadone Hydrochloride Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76291 ORIG 2023-11-03