Application 078939

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	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
A078939-001	ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2009-06-17
A078939-002	ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2009-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078939-001	AB
A078939-002	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 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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078939-001	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2009-06-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078939-002	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2009-06-17	`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	A078939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078939-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078939-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078939-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078939-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078939-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078939-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078939-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078939-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078939-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078939-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078939-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078939-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078939-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078939-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078939-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078939-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078939-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078939-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078939-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078939-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078939-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078939-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078939-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078939-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078939-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078939-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078939-002	AB	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	REMEDYREPACK INC.	c12b3482-55f0-4324-bdcd-b129ca2dae73	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939 ndc (product): 70518-2966
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	REMEDYREPACK INC.	e0d4a594-d3e0-47b0-9f11-f4dbd4552d5a	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	c732b415-e1f9-478f-896d-1dc8b6362da4	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939 ndc (product): 68180-280 ndc (product): 68180-281
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	American Health Packaging	d32e9865-8edd-4644-9939-62ed119db3ef	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078939 application number: ANDA078939 ndc (product): 68084-280

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5140	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5140	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5142	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5142	Ethambutol Hydrochloride	Ethambutol Hydrochloride	A-S Medication Solutions	ANDA	Current
68084-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	American Health Packaging	ANDA	Current
68084-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	American Health Packaging	ANDA	Current
68084-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	American Health Packaging	ANDA	Current
68151-0149	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Carilion Materials Management	ANDA	Current
68180-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-280	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-281	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-281	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-281	Ethambutol Hydrochloride	Ethambutol Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2966	Ethambutol Hydrochloride	Ethambutol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2966	Ethambutol Hydrochloride	Ethambutol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2966	Ethambutol Hydrochloride	Ethambutol Hydrochloride	REMEDYREPACK INC.	ANDA	Current