Application 091189

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

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

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
A091189-001	METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2010-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091189-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`cb3db0bc1861…`

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	A091189-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091189-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091189-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091189-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091189-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091189-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091189-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091189-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091189-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091189-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091189-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091189-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091189-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091189-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091189-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091189-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091189-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091189-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091189-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091189-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091189-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091189-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091189-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091189-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091189-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091189-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091189-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091189-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091189-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091189-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091189-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091189-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091189-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091189-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091189-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091189-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091189-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091189-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091189-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091189-001	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 · 2 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	Exact identifier application applno (ANDA): 091189 application number: ANDA091189
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Commercial LLC	f31f580f-1f08-4a0f-b078-0b9e3308f712	2023-07-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091189 application number: ANDA091189 ndc (product): 68308-115

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68308-115	Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Inc.	ANDA	Current
68308-115	Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Inc.	ANDA	Current
68308-115	Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Inc.	ANDA	Current
68308-115	Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Inc.	ANDA	Current