Application 212862

Type: NDA
Sponsor: MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRETOMANID	PRETOMANID	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N212862-001	PRETOMANID	PRETOMANID	200MG	TABLET / ORAL		RLD, RS	2019-08-14

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212862-001	NCE	2024-08-14
N212862-001	ODE-253	2026-08-14
N212862-001	GAIN	2029-08-14
N212862-001	GAIN	2031-08-14

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N212862-001	NCE	2024-08-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212862-001	ODE-253	2026-08-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212862-001	GAIN	2029-08-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212862-001	GAIN	2031-08-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N212862-001	NCE	2024-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212862-001	ODE-253	2026-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212862-001	GAIN	2029-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212862-001	GAIN	2031-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212862-001	NCE	2024-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212862-001	ODE-253	2026-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212862-001	GAIN	2029-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212862-001	NCE	2024-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212862-001	ODE-253	2026-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212862-001	GAIN	2029-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	NCE	2024-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	ODE-253	2026-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	GAIN	2029-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212862-001	NCE	2024-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212862-001	ODE-253	2026-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212862-001	GAIN	2029-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	NCE	2024-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	ODE-253	2026-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	GAIN	2029-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	NCE	2024-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	ODE-253	2026-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	GAIN	2029-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	NCE	2024-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	ODE-253	2026-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	GAIN	2029-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	NCE	2024-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	ODE-253	2026-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	GAIN	2029-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	NCE	2024-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	ODE-253	2026-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	GAIN	2029-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	NCE	2024-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	ODE-253	2026-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	GAIN	2029-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212862-001	NCE	2024-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212862-001	ODE-253	2026-08-14	`d06236e962d9…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pretomanid	PRETOMANID	Viatris Specialty LLC	f1906fc9-cb3c-4e13-8a4a-da76100c1bf3	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212862 application number: NDA212862 ndc (product): 49502-476

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-476	Pretomanid	Pretomanid	Mylan Specialty L.P.	NDA	Current
49502-476	Pretomanid	Pretomanid	Mylan Specialty L.P.	NDA	Current
49502-476	Pretomanid	Pretomanid	Mylan Specialty L.P.	NDA	Current
49502-476	Pretomanid	Pretomanid	Mylan Specialty L.P.	NDA	Current
49502-476	Pretomanid	Pretomanid	Mylan Specialty LP	NDA	Current
49502-476	Pretomanid	Pretomanid	Mylan Specialty L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80424	SUPPL	2024-11-26
80355	SUPPL	2024-11-25
80354	SUPPL	2024-11-25
73007	SUPPL	2022-12-22
73006	SUPPL	2022-12-22
73000	SUPPL	2022-12-22
59986	ORIG	2019-09-12
59738	ORIG	2019-08-16
59702	ORIG	2019-08-14
59701	ORIG	2019-08-14