Application 200797

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	No	No
002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	No	No
003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	No	No
004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	No	No
005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03

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.

Product history page 1 of 6 · 215 observed 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	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL		2015-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL		2015-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL		2015-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200797-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200797-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200797-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200797-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200797-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-03	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200797-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200797-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200797-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200797-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200797-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200797-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200797-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200797-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200797-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200797-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200797-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200797-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200797-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200797-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200797-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200797-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200797-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200797-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200797-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200797-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200797-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200797-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200797-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200797-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200797-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200797-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200797-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200797-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200797-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200797-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200797-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200797-005	AB	1	`5d02ea3f76ae…`

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
Amlodipine, Valsartan and Hydrochlorothiazide	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200797 application number: ANDA200797 ndc (product): 68180-773 ndc (product): 68180-772 ndc (product): 68180-774 ndc (product): 68180-771 ndc (product): 68180-775

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57297-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
68180-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current