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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Precision Dose, Inc.	978d0c83-bc01-49b2-a08a-61d72ee58ff8	2023-12-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	6c5f67b0-3788-44e7-8dce-bcd58883d4a0	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	36c3f916-cc4e-4e09-8419-4d6b64157e32	2023-11-11	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	ae3099cd-a88e-4273-bf7f-b68419d03b3e	2023-10-24	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	281b849d-c380-474c-94b1-1f3778504943	2023-08-29	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Chartwell RX, LLC	8a17033c-1ad3-4c7a-92ee-f55756833986	2023-04-03	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Bryant Ranch Prepack	418c4c4e-6195-4d0d-a559-ee3f10147b5b	2023-03-24	Boxed warning, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	Aphena Pharma Solutions - Tennessee, LLC	3bd33aec-9a30-4581-bd28-6cfb67772cef	2023-03-15	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	1d5450e9-85bb-471e-b6f3-c2ec7a34f128	2023-02-24	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	3296f664-8de0-4ccc-8346-ed2b1b0db027	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	47560d98-f4c4-4738-85fe-41cbed09ed59	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	8dcaeabf-e7da-4e0c-b6db-0bd425d6506e	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	TAGI Pharma, Inc.	89c9ff5e-8929-4e63-bc11-459aa9ce7110	2022-06-20	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	45d9b32a-3198-49d5-addf-f077fec50b9c	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	bc435603-ddc4-4083-af09-2e562defbe7f	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	46b4f05c-9261-42fc-a016-c99eebab5646	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	f4337699-3279-4c08-94f4-caba6d866f63	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	19f1e761-69e9-4330-ad3c-1f1180d70cb0	2021-01-01	Boxed warning, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Proficient Rx LP	9fb78c06-e527-4596-884c-fcf882927a33	2020-02-01	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