Home Applications 207537 Application 207537
Type ANDA
Sponsor PHARM ASSOC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML No No 002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207537-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 A207537-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01
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 2 · 78 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 2026-02-19 14:30 UTC 2026-02 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0406-6221 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE SpecGx LLC ANDA Current 0406-6225 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE SpecGx LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76449 ORIG 2023-11-07