Application 090122

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPROBAMATE	MEPROBAMATE	TABLET;ORAL	200MG	No	No
002	MEPROBAMATE	MEPROBAMATE	TABLET;ORAL	400MG	No	No

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

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
A090122-001	MEPROBAMATE	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18
A090122-002	MEPROBAMATE	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090122-001	AA
A090122-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA		2009-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA		2009-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090122-001	MEPROBAMATE	200MG	TABLET / ORAL	AA	RS	2009-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090122-002	MEPROBAMATE	400MG	TABLET / ORAL	AA	RS	2009-02-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090122-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090122-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090122-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090122-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090122-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090122-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090122-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090122-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090122-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090122-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090122-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090122-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090122-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090122-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090122-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090122-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090122-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090122-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090122-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090122-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090122-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090122-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090122-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090122-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090122-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090122-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090122-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090122-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090122-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090122-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090122-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090122-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090122-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090122-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090122-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090122-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090122-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090122-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090122-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090122-002	AA	1	`782e0a99824c…`

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
MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	a0891a32-105b-48bc-a246-5e179d2e7fa1	2023-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090122 application number: ANDA090122 ndc (product): 46708-019 ndc (product): 46708-020
Meprobamate	MEPROBAMATE	Alembic Pharmaceuticals Inc.	3b255bcd-0218-44f8-830b-971f5ec45276	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090122 application number: ANDA090122 ndc (product): 62332-019 ndc (product): 62332-020

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
46708-019	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-019	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-019	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-020	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-020	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-020	MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-019	Meprobamate	Meprobamate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-019	Meprobamate	Meprobamate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-020	Meprobamate	Meprobamate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-020	Meprobamate	Meprobamate	Alembic Pharmaceuticals Inc.	ANDA	Current