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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE	VistaPharm, LLC	4a44bde6-c348-4316-b0e0-c24b407cb823	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	VistaPharm, LLC	4c8b541c-33e8-4969-b258-af150808d46e	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Aurolife Pharma, LLC	6984eb5a-57a3-4686-bc67-91bc3e7a531e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Epic Pharma, LLC	6da7501b-b881-4bc7-891a-74214a00a3ac	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Elite Laboratories, Inc.	d702d32b-98b1-412d-934c-1cd96af4b95a	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
DISKETS	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e6af84de-cbfc-4a3b-bd73-6bcf77337168	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Precision Dose, Inc.	cbc42334-8783-4572-b8da-8c7451d14077	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	50f14803-78c0-4d19-8b5d-9a9c17582ac1	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHADONE HYDROCHLORIDE generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc	8f4cf84e-165c-489d-a668-0f715053f196	2025-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1a6dbcb0-68f2-4f8b-94ee-baa2aa296293	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Atlantic Biologicals Corp.	373c649e-798d-770e-e063-6294a90a6e47	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	American Health Packaging	f935effe-e5b2-4bf7-bbde-6e80bb99076f	2025-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Precision Dose, Inc.	e980d666-d74d-4358-a3b7-c6accb15eba6	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	1a536622-dda3-41af-ab08-28e7c1bc9300	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methadone Hydrochloride generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	7a8635fe-6183-4cda-9029-50e4e6dd5832	2023-11-06	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