Application 203016

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	2MG	No	No
002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	4MG	No	No

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

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
A203016-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2015-08-11
A203016-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2015-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203016-001	AB
A203016-002	AB

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 · 84 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	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A203016-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203016-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203016-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203016-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203016-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203016-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203016-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203016-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203016-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203016-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203016-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203016-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203016-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203016-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203016-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203016-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203016-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203016-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	db6e0b6d-0ce5-41d7-881f-881c11f530a4	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203016 application number: ANDA203016 ndc (product): 13668-189 ndc (product): 13668-190
Tolterodine Tartrate	TOLTERODINE	American Health Packaging	8cd23ff7-71ba-4391-95bd-a3a7f347713d	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203016 application number: ANDA203016 ndc (product): 60687-319 ndc (product): 60687-330

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6592	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
0904-6592	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
0904-6592	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
0904-6593	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
0904-6593	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
0904-6593	TOLTERODINE TARTRATE	TOLTERODINE	Major Pharmaceuticals	ANDA	Current
13668-189	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-189	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-189	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-189	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-190	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-190	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-190	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-190	TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	ANDA	Current
60687-319	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current
60687-319	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current
60687-319	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current
60687-330	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current
60687-330	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current
60687-330	Tolterodine Tartrate	Tolterodine	American Health Packaging	ANDA	Current