Application 208305

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

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 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
A208305-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL			2018-03-30
A208305-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL			2018-03-30

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		2018-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		2018-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2018-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2018-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2018-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2018-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2018-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2018-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208305-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2018-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208305-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2018-03-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208305-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208305-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208305-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208305-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208305-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208305-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208305-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208305-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208305-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208305-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208305-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208305-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208305-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208305-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208305-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208305-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208305-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208305-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208305-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208305-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208305-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208305-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208305-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208305-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208305-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208305-002	AA	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208305-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208305-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208305-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208305-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208305-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208305-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208305-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208305-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208305-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208305-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208305-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208305-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208305-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208305-002	AA	1	`e64feba35796…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	American Health Packaging	540edd43-165d-4257-b989-3bccc8f54afb	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
METHADOSE DISPERSIBLE	METHADONE HYDROCHLORIDE	SpecGx LLC	544483e6-6f9d-4371-9e93-313e54e0ea05	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHADONE HYDROCHLORIDE generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	SpecGx LLC	14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Major Pharmaceuticals	db52fdc0-765a-4fad-a8f9-ef98c6e4b898	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHADONE HYDROCHLORIDE generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	d7b30c78-c531-4dc5-9552-d68daa3210d1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Long Grove Pharmaceuticals, LLC	f453f1b9-d46e-4be8-835d-dbeb9d98a149	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Breckenridge Pharmaceutical Inc	13541167-95f4-4cb9-9d7d-3c1aced5c5f6	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SpecGx LLC	5baef1bf-8bf0-429c-a4ce-1c93171f3f15	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHADONE HYDROCHLORIDE generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SpecGx LLC	eddf7077-02fb-4771-9823-31984f4ff2bb	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHADONE HYDROCHLORIDE generic name: METHADONE HYDROCHLORIDE
METHADOSE	METHADONE HYDROCHLORIDE	SpecGx LLC	808a9d0b-720b-4034-a862-5122ff514608	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Ascend Laboratories, LLC	f0366917-f745-4b01-a662-a98a7d80b4a0	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	f9dad5d5-3417-4992-99ee-6550f81add6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	VistaPharm, LLC	7ff89589-149c-4007-8144-5f60131b8c33	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	d0e6a966-179a-45e0-8444-4c1b8523f8d2	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA	e72841bf-364b-49b1-8e69-7e26ddcd2657	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	VistaPharm, LLC	d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	VistaPharm, LLC	c54baaee-8ea4-45f5-a5c8-bb84cf86832f	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Lannett Company, Inc.	0955ea4a-c6b8-431f-ba42-9641b5b102ea	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Mylan Institutional LLC	092d78eb-6423-495c-bf0d-e6532bea7138	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE

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 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-602	Methadone hydrochloride	Methadone hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-603	Methadone hydrochloride	Methadone hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76294	ORIG	2023-11-03
53622	ORIG	2018-04-05