Application 012911

Type: NDA
Sponsor: HRA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPIRONE	METYRAPONE	TABLET;ORAL	250MG	No	No
002	METOPIRONE	METYRAPONE	CAPSULE;ORAL	250MG	Yes	Yes

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
N012911-001	METOPIRONE	METYRAPONE	250MG	TABLET / ORAL		Approved before 1982
N012911-002	METOPIRONE	METYRAPONE	250MG	CAPSULE / ORAL		RLD, RS	1996-08-09

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	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012911-001	METOPIRONE	250MG	TABLET / ORAL	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012911-002	METOPIRONE	250MG	CAPSULE / ORAL	RLD, RS	1996-08-09	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metopirone	METYRAPONE	ESTEVE PHARMACEUTICALS, S.A.	4046b167-7a46-8f4a-e063-6394a90a147f	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012911 application number: NDA012911
Metopirone	METYRAPONE	HRA Pharma Rare Diseases	3a27d0ef-83a7-4e1c-9430-46a3326ee8d8	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012911 application number: NDA012911 ndc (product): 76336-455

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
76336-455	Metopirone	Metyrapone	HRA Pharma Rare Diseases	NDA	Current
76336-455	Metopirone	Metyrapone	Laboratoire HRA Pharma	NDA	Current
76336-455	Metopirone	Metyrapone	HRA Pharma Rare Diseases	NDA	Current
76336-455	Metopirone	Metyrapone	HRA Pharma Rare Diseases	NDA	Current
76336-455	Metopirone	Metyrapone	HRA Pharma Rare Diseases	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74900	SUPPL	2023-07-27
74898	SUPPL	2023-07-26
72059	SUPPL	2022-09-10
72055	SUPPL	2022-09-09
61987	SUPPL	2020-02-27
61928	SUPPL	2020-02-21
56092	SUPPL	2018-10-24
56084	SUPPL	2018-10-23
10827	SUPPL	2014-03-04
348	SUPPL	2014-03-04
12041	SUPPL	2010-11-08
10826	SUPPL	2010-11-04
347	SUPPL	2004-05-07