Application 090372

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZAFIRLUKAST	ZAFIRLUKAST	TABLET;ORAL	10MG	No	No
002	ZAFIRLUKAST	ZAFIRLUKAST	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090372-001	ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET / ORAL	AB		2010-11-18
A090372-002	ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET / ORAL	AB		2010-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090372-001	AB
A090372-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090372-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2010-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090372-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2010-11-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090372-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090372-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090372-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090372-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090372-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090372-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090372-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090372-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090372-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090372-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090372-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090372-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090372-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090372-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090372-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090372-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090372-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090372-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090372-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090372-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090372-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090372-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090372-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090372-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090372-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090372-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090372-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090372-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090372-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090372-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090372-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090372-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090372-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090372-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090372-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090372-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090372-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090372-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090372-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090372-002	AB	1	`74a2ff9319b5…`

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
Zafirlukast	ZAFIRLUKAST	American Health Packaging	a60f39f6-d590-4b00-8751-7f12b7ec5385	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090372 application number: ANDA090372 ndc (product): 68084-059
Zafirlukast	ZAFIRLUKAST	Dr. Reddys Laboratories Limited	6ccb96af-2647-9206-5eee-49a825d32488	2018-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090372 application number: ANDA090372 ndc (product): 55111-625 ndc (product): 55111-626

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-805	Zafirlukast	Zafirlukast	AvPAK	ANDA	Current
50268-805	Zafirlukast	Zafirlukast	AvPAK	ANDA	Current
50268-805	Zafirlukast	Zafirlukast	AvPAK	ANDA	Current
55111-625	Zafirlukast	Zafirlukast	Dr. Reddys Laboratories Limited	ANDA	Current
55111-626	Zafirlukast	Zafirlukast	Dr. Reddys Laboratories Limited	ANDA	Current
68084-059	Zafirlukast	Zafirlukast	American Health Packaging	ANDA	Current
68084-059	Zafirlukast	Zafirlukast	American Health Packaging	ANDA	Current
68084-059	Zafirlukast	Zafirlukast	American Health Packaging	ANDA	Current
68151-1977	Zafirlukast	Zafirlukast	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31463	ORIG	2010-11-22