Application 016320

Type: NDA
Sponsor: STI PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	TABLET;ORAL	100MG	Yes	No
002	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	TABLET;ORAL	400MG	Yes	Yes
004	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	TABLET;ORAL	500MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016320-001	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016320-002	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	200MG	TABLET / ORAL		Approved before 1982
N016320-003	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N016320-004	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	500MG	TABLET / ORAL		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016320-001	AB
N016320-003	AB

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016320-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016320-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016320-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016320-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016320-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016320-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016320-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016320-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016320-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016320-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016320-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016320-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016320-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016320-003	AB	1	`4b0b4de00fa7…`

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
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	STI Pharma LLC	3f6428d6-3745-4337-ad78-ebfff9f49135	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320 ndc (product): 54879-001 ndc (product): 54879-002
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	Kanchan Healthcare Inc	e4ccab0e-84ff-447f-82ca-fa0a3989f6b7	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320

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 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0417	Myambutol	Ethambutol hydrochloride	A-S Medication Solutions	NDA	Current
50090-2337	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2399	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2607	Myambutol	Ethambutol hydrochloride	A-S Medication Solutions	NDA	Current
50090-2607	Myambutol	Ethambutol hydrochloride	A-S Medication Solutions	NDA	Current
53808-0977	Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	State of Florida DOH Central Pharmacy	NDA	Current
54879-001	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-001	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-001	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-001	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-002	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-002	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-002	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
54879-002	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma LLC	NDA AUTHORIZED GENERIC	Current
55695-023	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Department of State Health Services, Pharmacy Branch	NDA AUTHORIZED GENERIC	Current
55695-035	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Department of State Health Services, Pharmacy Branch	NDA AUTHORIZED GENERIC	Current
68850-004	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma	NDA AUTHORIZED GENERIC	Current
68850-005	Ethambutol Hydrochloride	Ethambutol Hydrochloride	STI Pharma	NDA AUTHORIZED GENERIC	Current
68850-010	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
68850-010	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
68850-010	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
68850-012	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
68850-012	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
68850-012	Myambutol	Ethambutol hydrochloride	STI Pharma, LLC	NDA	Current
70518-0459	Ethambutol Hydrochloride	Ethambutol Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0459	Ethambutol Hydrochloride	Ethambutol Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2691	Myambutol	Ethambutol hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2691	Myambutol	Ethambutol hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2691	Myambutol	Ethambutol hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10884	SUPPL	2013-02-26
10883	SUPPL	2008-11-07
439	SUPPL	2008-11-03
33161	SUPPL	2004-04-05
12986	SUPPL	2004-03-28
33159	SUPPL	2003-06-10
33160	SUPPL	2003-02-06
12985	SUPPL	2003-02-06
10882	SUPPL	2003-02-06
438	SUPPL	2003-02-06