Application 020547

Type: NDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACCOLATE	ZAFIRLUKAST	TABLET;ORAL	20MG	Yes	Yes
003	ACCOLATE	ZAFIRLUKAST	TABLET;ORAL	10MG	Yes	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
N020547-001	ACCOLATE	ZAFIRLUKAST	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26
N020547-003	ACCOLATE	ZAFIRLUKAST	10MG	TABLET / ORAL	AB	RLD	1999-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020547-001	AB
N020547-003	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 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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020547-001	ACCOLATE	20MG	TABLET / ORAL	AB	RLD, RS	1996-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020547-003	ACCOLATE	10MG	TABLET / ORAL	AB	RLD	1999-09-17	`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	N020547-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020547-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020547-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020547-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020547-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020547-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020547-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020547-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020547-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020547-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020547-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020547-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020547-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020547-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020547-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020547-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020547-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020547-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020547-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020547-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020547-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020547-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020547-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020547-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020547-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020547-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020547-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020547-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020547-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020547-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020547-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020547-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020547-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020547-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020547-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020547-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020547-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020547-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020547-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020547-003	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	Strides Pharma Science Limited	baba507f-6557-4551-815c-9ab6606e4ee1	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020547 application number: NDA020547 ndc (product): 64380-188 ndc (product): 64380-187
Zafirlukast	ZAFIRLUKAST	AvKARE	f89a821d-396f-a3aa-e053-6294a90a4577	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020547 application number: NDA020547

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6646	Zafirlukast	zafirlukast	Major Pharmaceuticals	NDA	Current
0904-6646	Zafirlukast	zafirlukast	Major Pharmaceuticals	NDA	Current
49884-010	ACCOLATE	zafirlukast	Par Pharmaceutical Inc.	NDA	Current
49884-010	ACCOLATE	zafirlukast	Par Pharmaceutical Inc.	NDA	Current
49884-011	ACCOLATE	zafirlukast	Par Pharmaceutical Inc.	NDA	Current
49884-549	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-549	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-549	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-549	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-554	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-554	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-554	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-554	Zafirlukast	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-589	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-589	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-589	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-589	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-590	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-590	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-590	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
49884-590	Accolate	zafirlukast	Par Pharmaceutical, Inc.	NDA	Current
53808-0203	ACCOLATE	Zafirlukast	State of Florida DOH Central Pharmacy	NDA	Current
63629-2102	Zafirlukast	zafirlukast	Bryant Ranch Prepack	NDA	Current
63629-2102	Zafirlukast	zafirlukast	Bryant Ranch Prepack	NDA	Current
63629-2102	Zafirlukast	zafirlukast	Bryant Ranch Prepack	NDA	Current
64380-177	ACCOLATE	Zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-178	ACCOLATE	Zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-187	Zafirlukast	zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-187	Zafirlukast	zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-188	Zafirlukast	zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-188	Zafirlukast	zafirlukast	Strides Pharma Science Limited	NDA	Current
64380-188	Zafirlukast	zafirlukast	Strides Pharma Science Limited	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
34809	SUPPL	2013-11-22
25152	SUPPL	2013-11-18
25151	SUPPL	2011-08-10
12709	SUPPL	2011-08-08
34808	SUPPL	2010-10-19
2702	SUPPL	2010-10-19
12708	SUPPL	2010-07-19
25150	SUPPL	2010-07-15
2701	SUPPL	2009-11-19
12707	SUPPL	2009-08-28
25149	SUPPL	2008-06-02
34807	SUPPL	2005-06-08
25148	SUPPL	2005-06-08
41421	SUPPL	2004-05-25
25147	SUPPL	2004-05-25
20712	SUPPL	2004-05-25
20711	SUPPL	2004-04-14
34806	SUPPL	2004-04-05
2700	SUPPL	2003-07-29
2699	SUPPL	1999-09-17
57448	ORIG	1997-04-10