Application 005378

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	Yes
003	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
004	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
005	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N005378-002	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982
N005378-003	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982
N005378-004	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982
N005378-005	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		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
N005378-002	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005378-002	DESOXYN	5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005378-003	DESOXYN	10MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005378-004	DESOXYN	5MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005378-005	DESOXYN	15MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982	`d06236e962d9…`

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	N005378-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005378-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005378-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005378-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005378-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005378-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005378-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005378-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005378-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005378-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005378-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005378-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005378-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005378-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005378-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005378-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005378-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005378-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005378-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005378-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005378-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N005378-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N005378-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N005378-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N005378-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N005378-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N005378-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N005378-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N005378-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N005378-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N005378-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N005378-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N005378-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N005378-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N005378-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N005378-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N005378-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N005378-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N005378-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N005378-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHAMPHETAMINE HYDROCHLORIDE
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	90c02ac6-e5e2-4c97-8c68-81e4e389a195	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHAMPHETAMINE HYDROCHLORIDE
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Commercial LLC	f31f580f-1f08-4a0f-b078-0b9e3308f712	2023-07-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHAMPHETAMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-104	Desoxyn	methamphetamine hydrochloride	Recordati Rare Diseases Inc.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	Recordati Rare Diseases, Inc.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
70868-820	Desoxyn	methamphetamine hydrochloride	Key Therapeutics	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79741	SUPPL	2024-09-26
79740	SUPPL	2024-09-26
79732	SUPPL	2024-09-26
75809	SUPPL	2023-10-17
75757	SUPPL	2023-10-16
70329	SUPPL	2022-03-01
70328	SUPPL	2022-03-01
70294	SUPPL	2022-02-28
58845	SUPPL	2019-05-23
58844	SUPPL	2019-05-23
58328	SUPPL	2019-04-15
48507	SUPPL	2017-05-24
48483	SUPPL	2017-05-22
46795	SUPPL	2017-01-11
46719	SUPPL	2017-01-06
63	SUPPL	2015-04-21
32931	SUPPL	2015-04-20
62	SUPPL	2013-12-09
32930	SUPPL	2013-12-04
32929	SUPPL	2013-08-27
15	SUPPL	2013-08-27
43993	ORIG	2011-12-20
10677	SUPPL	2007-05-16
61	SUPPL	2007-05-16
32928	SUPPL	2006-04-13
60	SUPPL	2006-04-13
32927	SUPPL	2003-04-03