Application 089897

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE INTENSOL	METHADONE HYDROCHLORIDE	CONCENTRATE;ORAL	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089897-001	METHADONE HYDROCHLORIDE INTENSOL	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		1988-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089897-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`e64feba35796…`

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
2026-08-18 06:07:40	2026-07	A089897-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089897-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089897-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089897-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089897-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089897-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089897-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089897-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089897-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089897-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089897-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089897-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089897-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089897-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089897-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089897-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089897-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089897-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089897-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089897-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089897-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089897-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089897-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089897-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089897-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089897-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089897-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089897-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089897-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089897-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089897-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089897-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089897-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089897-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089897-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089897-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089897-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089897-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089897-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089897-001	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	d0e6a966-179a-45e0-8444-4c1b8523f8d2	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089897 application number: ANDA089897 ndc (product): 0054-3553
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA	e72841bf-364b-49b1-8e69-7e26ddcd2657	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089897 application number: ANDA089897 ndc (product): 0054-0391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0391	Methadone Hydrochloride	Methadone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0391	Methadone Hydrochloride	Methadone Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0391	Methadone Hydrochloride	Methadone Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0391	Methadone Hydrochloride	Methadone Hydrochloride	Hikma Pharmaceuticals USA	ANDA	Current
0054-0391	Methadone Hydrochloride	Methadone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3553	Methadone Hydrochloride	Methadone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3553	Methadone Hydrochloride	Methadone Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
17856-3553	Methadone Hydrochloride	Methadone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
70166-284	Methadone Hydrochloride	Methadone Hydrochloride	Lohxa	ANDA	Current
70166-284	Methadone Hydrochloride	Methadone Hydrochloride	Lohxa	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44544	ORIG	2015-06-30
18532	SUPPL	2014-05-06
44413	ORIG	2006-11-27