Application 021435

Type: NDA
Sponsor: DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMVAZ	AMLODIPINE MALEATE	TABLET;ORAL	2.5MG	No	No
002	AMVAZ	AMLODIPINE MALEATE	TABLET;ORAL	5MG	No	No
003	AMVAZ	AMLODIPINE MALEATE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
N021435-001	AMVAZ	AMLODIPINE MALEATE	2.5MG	TABLET / ORAL	2003-10-31
N021435-002	AMVAZ	AMLODIPINE MALEATE	5MG	TABLET / ORAL	2003-10-31
N021435-003	AMVAZ	AMLODIPINE MALEATE	10MG	TABLET / ORAL	2003-10-31

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021435-001	AMVAZ	2.5MG	TABLET / ORAL	2003-10-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021435-002	AMVAZ	5MG	TABLET / ORAL	2003-10-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021435-003	AMVAZ	10MG	TABLET / ORAL	2003-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021435-001	AMVAZ	2.5MG	TABLET / ORAL	2003-10-31	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021435-002	AMVAZ	5MG	TABLET / ORAL	2003-10-31	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021435-003	AMVAZ	10MG	TABLET / ORAL	2003-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021435-001	AMVAZ	2.5MG	TABLET / ORAL	2003-10-31	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021435-002	AMVAZ	5MG	TABLET / ORAL	2003-10-31	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021435-003	AMVAZ	10MG	TABLET / ORAL	2003-10-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021435-001	AMVAZ	2.5MG	TABLET / ORAL	2003-10-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021435-002	AMVAZ	5MG	TABLET / ORAL	2003-10-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021435-003	AMVAZ	10MG	TABLET / ORAL	2003-10-31	`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
27762	ORIG	2003-11-28