Application 204928

Type: ANDA
Sponsor: RISING PHARMS

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
A204928-001	ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET / ORAL	AB		2022-08-25
A204928-002	ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET / ORAL	AB		2022-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204928-001	AB
A204928-002	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 2 · 58 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	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204928-001	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	2022-08-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204928-002	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	2022-08-25	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A204928-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204928-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204928-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204928-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204928-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204928-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204928-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204928-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204928-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204928-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204928-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204928-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204928-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204928-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204928-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204928-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204928-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204928-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204928-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204928-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204928-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204928-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204928-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204928-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204928-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204928-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204928-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204928-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204928-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204928-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204928-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204928-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204928-002	AB	1	`a72a2bbeb626…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zafirlukast	ZAFIRLUKAST	Strides Pharma Science Limited	baba507f-6557-4551-815c-9ab6606e4ee1	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	AvKARE	f89a821d-396f-a3aa-e053-6294a90a4577	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	American Health Packaging	a60f39f6-d590-4b00-8751-7f12b7ec5385	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	Bryant Ranch Prepack	d2256673-fe8b-4fba-a73a-a81e24e47cf8	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	Aurobindo Pharma Limited	8bdb47c5-9d19-4d59-94c8-62c117525e7f	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	Camber Pharmaceuticals, Inc.	5d30ffab-38a1-411d-94ad-0a15c227d882	2020-09-14	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST
Zafirlukast	ZAFIRLUKAST	Dr. Reddys Laboratories Limited	6ccb96af-2647-9206-5eee-49a825d32488	2018-11-16	Warnings, Adverse reactions	Name fallback brand name: Zafirlukast generic name: ZAFIRLUKAST

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-654	Zafirlukast	Zafirlukast	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-654	Zafirlukast	Zafirlukast	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-655	Zafirlukast	Zafirlukast Tablets	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-655	Zafirlukast	Zafirlukast Tablets	Rising Pharmaceuticals, Inc.	ANDA	Current