Application 040587

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZONATATE	BENZONATATE	CAPSULE;ORAL	100MG	No	No
002	BENZONATATE	BENZONATATE	CAPSULE;ORAL	200MG	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
A040587-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL			2008-03-19
A040587-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL			2008-03-19

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040587-001	BENZONATATE	100MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040587-002	BENZONATATE	200MG	CAPSULE / ORAL	2008-03-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A040587-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040587-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040587-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040587-002	AA	1	`ea99ee380514…`

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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Proficient Rx LP	0d14cbf4-f43f-4ad2-8e8b-7a844e417702	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Proficient Rx LP	27156dad-64d6-4ea4-a3da-29e8e096fb01	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	a7b12862-1c9f-4712-93e6-a859b24728c2	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Bryant Ranch Prepack	143a5ba8-0ee9-43be-a0da-2c455c1a46bd	2019-09-11	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51655-771	Benzonatate	Benzonatate	Northwind Pharmaceuticals	ANDA	Current
57664-133	BENZONATATE	BENZONATATE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-134	BENZONATATE	BENZONATATE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
61919-638	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
61919-638	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
63187-339	BENZONATATE	BENZONATATE	Proficient Rx LP	ANDA	Current
68788-9054	BENZONATATE	BENZONATATE	Preferred Pharmaceuticals, Inc.	ANDA	Current
75921-133	BENZONATATE	BENZONATATE	Life Line Home Care Services, Inc.	ANDA	Current