Application 208920

Type
ANDA
Sponsor
YILING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL20MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL30MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208920-001LISINOPRILLISINOPRIL20MGTABLET / ORALAB2021-03-04
A208920-002LISINOPRILLISINOPRIL30MGTABLET / ORALAB2021-03-04
A208920-003LISINOPRILLISINOPRIL40MGTABLET / ORALAB2021-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208920-001AB
A208920-002AB
A208920-003AB

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 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-002LISINOPRIL30MGTABLET / ORALAB2021-03-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-003LISINOPRIL40MGTABLET / ORALAB2021-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208920-001LISINOPRIL20MGTABLET / ORALAB2021-03-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208920-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208920-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208920-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208920-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208920-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208920-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208920-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208920-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208920-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208920-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208920-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208920-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208920-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208920-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208920-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208920-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208920-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208920-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208920-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208920-001AB18072bd15b7f6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILChartwell RX, LLC8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208920
application number: ANDA208920

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69117-0012LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0012LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0012LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0014LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0014LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0014LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0015LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0015LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent
69117-0015LisinoprilLisinoprilYiling Pharmaceutical, Inc.ANDACurrent