Application 021228

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

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

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
N021228-001	DETROL LA	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22
N021228-002	DETROL LA	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021228-001	AB
N021228-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`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	N021228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021228-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021228-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021228-001	6770295	2019-08-26	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6630162	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6770295	2019-08-26	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6630162	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6911217	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6770295	2019-08-26	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6630162	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6770295	2019-08-26	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6630162	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6911217	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6770295	2019-08-26	U-544	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6630162	2019-11-11	U-544	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`b00525d2431f…`

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 · 17 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 generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Major Pharmaceuticals	e4b9ef09-c750-4e35-96fc-e759ba4849d8	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	A-S Medication Solutions	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	2026-01-09	Warnings, Adverse reactions	Name fallback 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 generic name: TOLTERODINE TARTRATE
Tolterodine tartrate	TOLTERODINE TARTRATE	Ajanta Pharma USA Inc.	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	2025-11-03	Warnings, Adverse reactions	Name fallback generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	ANI Pharmaceuticals, Inc.	fc5bdc4a-a483-4d31-807b-c7f8d8869723	2025-04-01	Warnings, Adverse reactions	Name fallback 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 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 generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Mylan Pharmaceuticals Inc.	9e432622-2e6f-4cf8-892f-510288dd50f2	2024-09-21	Warnings, Adverse reactions	Name fallback 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 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 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 generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Camber Pharmaceuticals, Inc.	f67fce7c-69d3-42ae-8c1d-2e26fd4d7415	2021-08-16	Warnings, Adverse reactions	Name fallback 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 generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Proficient Rx LP	b77f9893-a422-423a-bb27-527377ade36d	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: TOLTERODINE TARTRATE
Tolterodine Tartrate	TOLTERODINE TARTRATE	Camber Pharmaceuticals, Inc.	e16012ae-5972-470b-8a22-b0626a029e95	2017-06-03	Warnings, Adverse reactions	Name fallback generic name: TOLTERODINE TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-5190	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5190	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5190	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5191	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5191	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5191	Detrol LA	tolterodine tartrate	Pharmacia and Upjohn Company LLC	NDA	Current
0093-2049	Tolterodine Tartrate	Tolterodine Tartrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
0093-2050	Tolterodine Tartrate	Tolterodine Tartrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
55154-3933	Detrol LA	tolterodine tartrate	Cardinal Health	NDA	Current
55154-3935	Detrol LA	tolterodine tartrate	Cardinal Health	NDA	Current
55289-132	Detrol LA	tolterodine tartrate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-132	Detrol LA	tolterodine tartrate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-132	Detrol LA	tolterodine tartrate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-132	Detrol LA	tolterodine tartrate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
59762-0047	Tolterodine Tartrate Extended Release	tolterodine tartrate	Greenstone LLC	NDA	Current
59762-0048	Tolterodine Tartrate Extended Release	tolterodine tartrate	Greenstone LLC	NDA	Current
68151-4247	Tolterodine Tartrate	Tolterodine Tartrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-4281	Tolterodine Tartrate	Tolterodine Tartrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
69189-5190	Detrol LA	tolterodine tartrate	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54929	SUPPL	2018-07-20
54920	SUPPL	2018-07-19
47866	SUPPL	2017-04-05
4707	SUPPL	2012-08-03
14682	SUPPL	2012-08-02
36419	SUPPL	2011-09-23
4706	SUPPL	2011-09-23
36418	SUPPL	2010-01-08
27140	SUPPL	2010-01-06
4705	SUPPL	2008-09-15
42042	SUPPL	2007-06-11
42041	SUPPL	2007-06-11
42040	SUPPL	2007-06-11
21527	SUPPL	2007-06-11
4704	SUPPL	2007-03-23
14681	SUPPL	2005-10-25
4703	SUPPL	2005-10-25
36417	SUPPL	2005-07-21
27139	SUPPL	2005-07-21
36416	SUPPL	2004-05-03
27138	SUPPL	2004-04-20
21526	ORIG	2004-02-11
4702	SUPPL	2004-01-22
27137	SUPPL	2003-07-28
14680	SUPPL	2003-05-01
36415	ORIG	2000-12-22
4701	ORIG	2000-12-22
53140	ORIG	1900-01-01
53139	ORIG	1900-01-01
53138	ORIG	1900-01-01
53137	ORIG	1900-01-01
53136	ORIG	1900-01-01
53135	ORIG	1900-01-01
53134	ORIG	1900-01-01
53133	ORIG	1900-01-01