Levofloxacin

Product NDC
51655-250
11-digit product format
516550250
Labeler code
51655
Product ID
51655-250_1b0811e1-8f5b-4d6f-8985-62717e13ae2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA200839
Marketing category
ANDA
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-250DDiscontinued by firm2026-08-17
excluded packagepackage51655-25051655-250-07DDiscontinued by firm2026-08-17
excluded packagepackage51655-25051655-250-10DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-250-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-250-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-250-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-250-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-250-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-250-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-250-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-250-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-250-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-250-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-250-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-250-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-250-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-250-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-250-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-250-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-250-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-250-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-250-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-250-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-250-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-250-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-250-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-250-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-250-078af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-250-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-250-07834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-250-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-250-071332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-250-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-250-07fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-250-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-250-0786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-250-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-250-07bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-250-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-250-078dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-250-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-250-07e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-250-10e2bbac7714bc…27bdfed8d636…

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

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
A200839-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-03-22
A200839-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-03-22
A200839-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200839-001AB
A200839-002AB
A200839-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A200839-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51655-250-072026-01-10Levofloxacin
51655-250-102026-01-10Levofloxacin
51655-250-072020-01-31Levofloxacin
51655-250-102020-01-31Levofloxacin

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-250LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Legacy NDC20150121_7fa92e42-2831-4073-b9b2-3045dee74a74.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839
LevofloxacinLEVOFLOXACINMacleods Pharmaceuticals Limitedfc165a6d-24b0-4753-a7ac-94a134dca0d32023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839