Application 211312

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	TABLET;ORAL	5MG	No	No
002	DAPAGLIFLOZIN	DAPAGLIFLOZIN	TABLET;ORAL	10MG	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
A211312-001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB		2026-04-06
A211312-002	DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB		2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211312-001	AB
A211312-002	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A211312-001	PC	2026-10-03
A211312-002	PC	2026-10-03

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	A211312-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB		2026-04-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211312-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB		2026-04-06	`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	A211312-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211312-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	A211312-001	PC	2026-10-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211312-002	PC	2026-10-03	`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
Dapagliflozin	DAPAGLIFLOZIN	Sandoz Inc	8296f538-4c23-4d6c-be53-8005b83c24b7	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211312 application number: ANDA211312

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59597	ORIG	2019-08-06