Application 208427

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	LINAGLIPTIN;METFORMIN HYDROCHLORIDE	UNKNOWN	UNKNOWN	No	No
002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG; 850MG	No	No
003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG; 1G	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03
A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03
A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208427-001	AB
A208427-002	AB
A208427-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-001	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2025-11-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-002	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;850MG	TABLET / ORAL	AB	2025-11-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-003	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET / ORAL	AB	2025-11-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208427-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208427-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208427-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208427-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208427-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208427-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208427-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208427-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208427-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208427-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208427-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66712	ORIG	2021-03-10