Application 211518

Type: ANDA
Sponsor: ASCENT PHARMS 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	150MG	No	No
003	BENZONATATE	BENZONATATE	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211518-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22
A211518-002	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	AA	2019-02-22
A211518-003	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211518-001	AA
A211518-002	AA
A211518-003	AA

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 4 · 126 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
2026-08-18 06:07:40	2026-07	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211518-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211518-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211518-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211518-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211518-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211518-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211518-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211518-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211518-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211518-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211518-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211518-003	AA	1	`4b0b4de00fa7…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Sportpharm LLC	df48d617-a3c2-4776-937d-ccfca651d4fc	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da093b5e-83a7-467e-9716-bc5827a18c20	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	865a6317-c697-4dbe-9074-4a955036cdd7	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0f91fd98-1a86-42aa-8055-d339bff73015	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 63629-1229
Benzonatate	BENZONATATE	Anvi Pharmaceuticals Inc	7c733168-355e-4753-8d52-59a06fb39952	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Redpharm drug, inc	f3c23663-0cb7-ffa4-e053-2a95a90a9ae0	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Camber Pharmaceuticals, Inc.	c21afd18-3b04-4f15-874b-25e0c768f801	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 31722-958 ndc (product): 31722-956 ndc (product): 31722-957
Benzonatate	BENZONATATE	XLCare Pharmaceuticals, Inc.	e33afd96-5ad3-4033-b067-981ac2ed2bea	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 72865-118 ndc (product): 72865-117 ndc (product): 72865-119
Benzonatate	BENZONATATE	Preferred Pharmaceuticals, Inc.	fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da8fcba7-a43e-4463-96ac-104c7613d64f	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Direct_rx	2b4b22e9-a03d-fb8f-e063-6394a90a8747	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	REMEDYREPACK INC.	9815f3f4-fb46-4796-a0ed-62a9e098286d	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	A-S Medication Solutions	3268cde5-65ae-43d2-95c6-b8bb4c32a6fd	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 50090-6080
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	cfd54d90-c15d-0d02-e053-2995a90a8b28	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 68071-2562
Benzonatate	BENZONATATE	Proficient Rx LP	47560d98-f4c4-4738-85fe-41cbed09ed59	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 71205-699
Benzonatate	BENZONATATE	Proficient Rx LP	8dcaeabf-e7da-4e0c-b6db-0bd425d6506e	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 71205-673
Benzonatate	BENZONATATE	Proficient Rx LP	45d9b32a-3198-49d5-addf-f077fec50b9c	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 71205-853
Benzonatate	BENZONATATE	Proficient Rx LP	f4337699-3279-4c08-94f4-caba6d866f63	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 71205-887

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-956	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-956	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-957	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-957	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-958	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-958	Benzonatate	Benzonatate	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-6080	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
50090-6205	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
50090-6228	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
63629-1229	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-1229	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-1229	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
68071-2562	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-673	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-699	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-853	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-887	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-887	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
72865-117	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-117	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-118	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-118	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-119	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-119	Benzonatate	Benzonatate	XLCare Pharmaceuticals, Inc.	ANDA	Current