Application 202387

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	EQ 25MG BASE	No	No
002	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	EQ 50MG BASE	No	No
003	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	EQ 100MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202387-001	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	AB	2026-01-14
A202387-002	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET / ORAL	AB	2026-01-14
A202387-003	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET / ORAL	AB	2026-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202387-001	AB
A202387-002	AB
A202387-003	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A202387-001	PC	2026-11-24
A202387-002	PC	2026-11-24
A202387-003	PC	2026-11-24

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202387-001	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-002	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-003	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202387-001	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202387-002	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202387-003	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-001	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-002	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-003	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202387-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202387-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202387-003	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	A202387-001	PC	2026-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-002	PC	2026-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202387-003	PC	2026-11-24	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-001	PC	2026-11-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-002	PC	2026-11-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202387-003	PC	2026-11-24	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sitagliptin Phosphate	SITAGLIPTIN PHOSPHATE	Sandoz Inc	cebc8388-c9db-4e27-8d6b-0d9bdc9d766d	2026-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202387 application number: ANDA202387

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69852	ORIG	2022-01-12