Application 213397

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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 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
A213397-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19
A213397-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213397-001	AB
A213397-002	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.

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
2026-08-01 22:54:32	2026-06	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A213397-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213397-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine tartrate	TOLTERODINE TARTRATE	Ajanta Pharma USA Inc.	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213397 application number: ANDA213397 ndc (product): 27241-192 ndc (product): 27241-191

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-191	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-191	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma Limited	ANDA	Current
27241-191	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma Limited	ANDA	Current
27241-192	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-192	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma Limited	ANDA	Current
27241-192	Tolterodine tartrate	Tolterodine tartrate	Ajanta Pharma Limited	ANDA	Current