Application 091133

Type: ANDA
Sponsor: STRIDES PHARMA

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 1.

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
A091133-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2015-07-30
A091133-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2015-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091133-001	AA
A091133-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091133-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091133-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091133-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091133-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091133-002	AA	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZONATATE	BENZONATATE	Strides Pharma Science Limited	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133 ndc (product): 64380-712 ndc (product): 64380-713
Benzonatate	BENZONATATE	AvKARE	0b50405c-d399-edcd-e063-6294a90a89c2	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	f3c2acfc-f598-50ab-e053-2a95a90a11e7	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	NCS HealthCare of KY, LLC dba Vangard Labs	6f5c19ad-d811-4196-a9c3-4f6b89626b83	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133 ndc (product): 0615-8403

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8403	Benzonatate	Benzonatate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
64380-712	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-712	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-712	Benzonatate	Benzonatate	Strides Shasun Limited	ANDA	Current
64380-712	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-712	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-713	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-713	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-713	Benzonatate	Benzonatate	Strides Shasun Limited	ANDA	Current
64380-713	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
64380-713	Benzonatate	Benzonatate	Strides Pharma Science Limited	ANDA	Current
68071-1877	Benzonatate	Benzonatate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-7014	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7014	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-925	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-925	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current