Application 201486

Type: ANDA
Sponsor: MYLAN

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
A201486-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL			2013-10-31
A201486-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL			2013-10-31

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	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201486-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201486-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201486-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201486-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201486-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201486-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201486-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201486-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201486-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201486-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201486-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201486-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201486-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201486-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201486-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201486-002	AB	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 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine Tartrate	TOLTERODINE TARTRATE	Slate Run Pharmaceuticals, LLC	bbbee85a-e5e2-24ec-e053-2995a90acfd8	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Major Pharmaceuticals	e4b9ef09-c750-4e35-96fc-e759ba4849d8	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
TOLTERODINE TARTRATE	TOLTERODINE	Torrent Pharmaceuticals Limited	db6e0b6d-0ce5-41d7-881f-881c11f530a4	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	A-S Medication Solutions	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Golden State Medical Supply, Inc.	05b92da2-923b-3c04-e063-6394a90a69a1	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE	American Health Packaging	8cd23ff7-71ba-4391-95bd-a3a7f347713d	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate
Tolterodine tartrate	TOLTERODINE TARTRATE	Ajanta Pharma USA Inc.	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	ANI Pharmaceuticals, Inc.	fc5bdc4a-a483-4d31-807b-c7f8d8869723	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Rising Pharma Holdings, Inc.	b9ba8ad2-27f6-4f18-bd84-73659047910e	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Teva Pharmaceuticals USA, Inc.	973f98b5-4e8a-42d9-ac69-d4333d21c362	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Mylan Pharmaceuticals Inc.	9e432622-2e6f-4cf8-892f-510288dd50f2	2024-09-21	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine tartrate	TOLTERODINE TARTRATE	Unichem Pharmaceuticals (USA), Inc.	9710ad7b-93c2-4ec1-95ff-597563be4314	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE
Detrol	TOLTERODINE TARTRATE	Viatris Specialty LLC	41eb00d2-64e3-4ec9-8732-4bfc81b04180	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: TOLTERODINE TARTRATE
Tolterodine tartrate	TOLTERODINE TARTRATE	Macleods Pharmaceuticals Limited	3f2291c3-7e3c-41be-afa6-ef73ce896e30	2022-11-19	Warnings, Adverse reactions	Name fallback brand name: Tolterodine tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Teva Pharmaceuticals USA, Inc.	d27e25b5-5d02-419f-b098-41fb162c5872	2022-10-11	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Camber Pharmaceuticals, Inc.	f67fce7c-69d3-42ae-8c1d-2e26fd4d7415	2021-08-16	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Unichem Pharmaceuticals (USA), Inc.	56e62829-5371-416a-90b3-4b6429532d25	2020-08-07	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Proficient Rx LP	b77f9893-a422-423a-bb27-527377ade36d	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Camber Pharmaceuticals, Inc.	e16012ae-5972-470b-8a22-b0626a029e95	2017-06-03	Warnings, Adverse reactions	Name fallback brand name: Tolterodine Tartrate generic name: TOLTERODINE TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3402	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3404	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-346	Tolterodine Tartrate	Tolterodine Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-197	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Institutional Inc.	ANDA	Current
51079-197	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Institutional Inc.	ANDA	Current
51079-198	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Institutional Inc.	ANDA	Current
51079-198	Tolterodine Tartrate	Tolterodine Tartrate	Mylan Institutional Inc.	ANDA	Current
60429-825	Tolterodine Tartrate	Tolterodine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-825	Tolterodine Tartrate	Tolterodine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-826	Tolterodine Tartrate	Tolterodine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-826	Tolterodine Tartrate	Tolterodine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
71610-002	Tolterodine Tartrate	Tolterodine Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current