Application 074184

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADOSE	METHADONE HYDROCHLORIDE	TABLET, FOR SUSPENSION;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074184-001	METHADOSE	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA		1993-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074184-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074184-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074184-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074184-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074184-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074184-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074184-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074184-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074184-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074184-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074184-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074184-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074184-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074184-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074184-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074184-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074184-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074184-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074184-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074184-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074184-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074184-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074184-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074184-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074184-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074184-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074184-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074184-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074184-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074184-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074184-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074184-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074184-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074184-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074184-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074184-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074184-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074184-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074184-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074184-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074184-001	AA	1	`cb3db0bc1861…`

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
METHADOSE DISPERSIBLE	METHADONE HYDROCHLORIDE	SpecGx LLC	544483e6-6f9d-4371-9e93-313e54e0ea05	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074184 application number: ANDA074184 ndc (product): 0406-0540

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
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
0406-0540	METHADOSE DISPERSIBLE	Methadone Hydrochloride	SpecGx LLC	ANDA	Current
60687-209	METHADOSE DISPERSIBLE	Methadone Hydrochloride	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44247	ORIG	2006-11-27