Application 203508

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL	LISINOPRIL	TABLET;ORAL	2.5MG	No	No
002	LISINOPRIL	LISINOPRIL	TABLET;ORAL	5MG	No	No
003	LISINOPRIL	LISINOPRIL	TABLET;ORAL	10MG	No	No
004	LISINOPRIL	LISINOPRIL	TABLET;ORAL	20MG	No	No
005	LISINOPRIL	LISINOPRIL	TABLET;ORAL	30MG	No	No
006	LISINOPRIL	LISINOPRIL	TABLET;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203508-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29
A203508-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29
A203508-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29
A203508-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29
A203508-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29
A203508-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A203508-001	AB
A203508-002	AB
A203508-003	AB
A203508-004	AB
A203508-005	AB
A203508-006	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.

Product history page 1 of 7 · 252 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
2026-08-18 06:07:40	2026-07	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2013-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2013-10-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203508-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203508-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203508-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203508-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203508-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203508-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203508-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203508-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203508-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203508-004	AB	1	`03ed91905a0d…`

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
lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	32eb18bc-a80d-4de1-8f38-e591d8f66870	2021-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203508 application number: ANDA203508 ndc (product): 43353-270 ndc (product): 43353-009 ndc (product): 43353-298 ndc (product): 43353-301 ndc (product): 43353-271
lisinopril	LISINOPRIL	Exelan Pharmaceuticals Inc.	1bc69836-a659-4e3b-84a7-a00b7c4dc268	2020-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203508 application number: ANDA203508 ndc (product): 76282-419 ndc (product): 76282-420 ndc (product): 76282-418 ndc (product): 76282-421 ndc (product): 76282-417 ndc (product): 76282-422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-417	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
31722-418	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
31722-419	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
31722-420	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
31722-421	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
31722-422	LISINOPRIL	LISINOPRIL	Camber Pharmaceuticals Inc.	ANDA	Current
43353-009	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-009	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-009	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-270	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-270	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-270	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-271	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-271	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-271	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-298	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-298	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-298	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-301	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-301	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-301	lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68788-9411	LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals, Inc.	ANDA	Current
76282-417	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-417	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-417	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-418	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-418	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-418	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-419	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-419	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-419	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-420	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-420	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-420	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-421	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-421	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-421	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-422	lisinopril	lisinopril	Exelan Pharmaceuticals In	ANDA	Current
76282-422	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-422	lisinopril	lisinopril	Exelan Pharmaceuticals Inc.	ANDA	Current