Application 021624

Type: NDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021624-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021624-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021624-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021624-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021624-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021624-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021624-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021624-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021624-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021624-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021624-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021624-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021624-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021624-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021624-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021624-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021624-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021624-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021624-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021624-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021624-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021624-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021624-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021624-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021624-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021624-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021624-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021624-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021624-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021624-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021624-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021624-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021624-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021624-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021624-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021624-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021624-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021624-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021624-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021624-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021624-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021624-001	AP	1	`3a93d1ddd44b…`

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
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Mylan Institutional LLC	092d78eb-6423-495c-bf0d-e6532bea7138	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021624 application number: NDA021624 ndc (product): 67457-217

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-217	Methadone Hydrochloride	Methadone Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-217	Methadone Hydrochloride	Methadone Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-217	Methadone Hydrochloride	Methadone Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-217	Methadone Hydrochloride	Methadone Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-217	Methadone Hydrochloride	Methadone Hydrochloride	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84685	SUPPL	2026-01-06
84602	SUPPL	2025-12-31
77004	SUPPL	2023-12-19
76916	SUPPL	2023-12-18
71188	SUPPL	2022-06-01
71145	SUPPL	2022-05-25
67697	SUPPL	2021-06-07
67684	SUPPL	2021-06-03
60287	SUPPL	2019-10-08
46352	SUPPL	2016-12-21
46289	SUPPL	2016-12-20
21760	SUPPL	2013-06-03
37346	SUPPL	2004-03-03
5871	SUPPL	2004-02-27