Application 200998

Type: ANDA
Sponsor: TARO

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 44.

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
A200998-001	MEPROBAMATE	MEPROBAMATE	200MG	TABLET / ORAL			2011-05-23
A200998-002	MEPROBAMATE	MEPROBAMATE	400MG	TABLET / ORAL			2011-05-23

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200998-001	MEPROBAMATE	200MG	TABLET / ORAL	2011-05-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200998-002	MEPROBAMATE	400MG	TABLET / ORAL	2011-05-23	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meprobamate	MEPROBAMATE	Cipla USA Inc.	17d814e2-b277-4dce-8615-e7fd7cab773f	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Meprobamate generic name: MEPROBAMATE
MEPROBAMATE	MEPROBAMATE	Alembic Pharmaceuticals Limited	a0891a32-105b-48bc-a246-5e179d2e7fa1	2023-01-10	Warnings, Adverse reactions	Name fallback brand name: MEPROBAMATE generic name: MEPROBAMATE
Meprobamate	MEPROBAMATE	Alembic Pharmaceuticals Inc.	3b255bcd-0218-44f8-830b-971f5ec45276	2021-10-01	Warnings, Adverse reactions	Name fallback brand name: Meprobamate generic name: MEPROBAMATE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4147	Meprobamate	Meprobamate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4148	Meprobamate	Meprobamate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
52549-4147	Meprobamate	Meprobamate	Taro Pharmaceutical Industries Ltd.	ANDA	Current
52549-4148	Meprobamate	Meprobamate	Taro Pharmaceutical Industries Ltd.	ANDA	Current