Application 011210

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESSALON	BENZONATATE	CAPSULE;ORAL	100MG	Yes	No
003	TESSALON	BENZONATATE	CAPSULE;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N011210-001	TESSALON	BENZONATATE	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982
N011210-003	TESSALON	BENZONATATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011210-001	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 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	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1999-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011210-003	TESSALON	200MG	CAPSULE / ORAL		RLD	1999-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011210-003	TESSALON	200MG	CAPSULE / ORAL		RLD	1999-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011210-001	TESSALON	100MG	CAPSULE / ORAL	AA	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011210-003	TESSALON	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1999-06-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	N011210-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011210-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011210-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011210-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011210-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011210-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011210-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011210-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011210-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011210-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011210-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011210-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011210-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011210-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011210-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011210-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011210-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011210-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011210-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011210-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011210-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011210-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011210-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011210-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011210-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011210-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011210-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011210-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011210-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011210-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011210-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011210-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011210-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011210-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011210-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011210-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011210-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011210-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011210-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011210-001	AA	1	`f41ea6bd6efb…`

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 2 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
benzonatate	BENZONATATE	Bryant Ranch Prepack	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	2026-05-28	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	540d2bc6-11dc-43d7-b616-b89d75b81cd1	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Anvi Pharmaceuticals Inc	7c733168-355e-4753-8d52-59a06fb39952	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm drug, inc	f3c23663-0cb7-ffa4-e053-2a95a90a9ae0	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Camber Pharmaceuticals, Inc.	c21afd18-3b04-4f15-874b-25e0c768f801	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	XLCare Pharmaceuticals, Inc.	e33afd96-5ad3-4033-b067-981ac2ed2bea	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Cardinal Health 107, LLC	b46f231a-65d3-400d-ae6b-3216830807a2	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Sportpharm LLC	0e8f2562-2449-430f-85bb-f9195644cdfa	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Zydus Pharmaceuticals USA Inc.	331c70dc-005e-4d96-a35c-4d2d810aa3b1	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc.	6f7f4a31-99ec-45ca-84d7-0be3640d1e0b	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc	3309040d-e240-42f6-9c51-5c54604a3896	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc.	f2cd05a6-2b8b-4731-b97b-b6677fbabbcf	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Preferred Pharmaceuticals, Inc.	fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da8fcba7-a43e-4463-96ac-104c7613d64f	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	b3b16ea5-4572-470e-8124-fc38b1d49e3e	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Direct_rx	2b4b22e9-a03d-fb8f-e063-6394a90a8747	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	14550e43-1d1f-4dc1-a3f2-aac0d78a7118	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	e1bf84c8-fc88-4f43-8655-7ce95a4da51f	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm Drug	4972e1e4-7eac-a770-e063-6294a90abe28	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: BENZONATATE
Benzonatate	BENZONATATE	AvKARE	0b50405c-d399-edcd-e063-6294a90a89c2	2026-01-14	Warnings, Adverse reactions	Name fallback 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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0122	Tessalon	benzonatate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0122	Tessalon	benzonatate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0122	Tessalon	benzonatate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0122	Tessalon	benzonatate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
59762-1122	Benzonatate	benzonatate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1122	Benzonatate	benzonatate	Greenstone LLC	NDA	Current
59762-1122	Benzonatate	benzonatate	Greenstone LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11924	SUPPL	2011-01-25
10757	SUPPL	2011-01-25