Application 205234

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;40MG	No	No
002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;40MG	No	No
003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;80MG	No	No
004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A205234-001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17
A205234-002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17
A205234-003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17
A205234-004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17

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 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-004	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A205234-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205234-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205234-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205234-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-004	AB	1	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Lupin Pharmaceuticals, Inc.	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Amlodipine
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Mylan Pharmaceuticals Inc.	ca60a4d5-ace7-4889-94ee-e2265fd63811	2018-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Telmisartan and Amlodipine

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-184	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-184	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-185	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-185	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-186	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-186	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-187	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-187	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46029	ORIG	2016-12-06