Finasteride

Product NDC
68554-3025
11-digit product format
685543025
Labeler code
68554
Product ID
68554-3025_ff5a9f04-1672-4eef-bfb0-df84189f8c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hetero Labs Limited
Application
ANDA090061
Marketing category
ANDA
Marketing start
2016-03-04
Marketing end
0000-00-00
Substance
FINASTERIDE
Active strength
5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68554-3025DDiscontinued by firm2026-08-17
excluded packagepackage68554-302568554-3025-0DDiscontinued by firm2026-08-17
excluded packagepackage68554-302568554-3025-1DDiscontinued by firm2026-08-17
excluded packagepackage68554-302568554-3025-2DDiscontinued by firm2026-08-17
excluded packagepackage68554-302568554-3025-3DDiscontinued by firm2026-08-17
excluded packagepackage68554-302568554-3025-4DDiscontinued 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 · 114 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 packagepackage68554-3025-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68554-3025-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68554-3025-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68554-3025-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68554-3025-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68554-3025-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68554-3025-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68554-3025-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68554-3025-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68554-3025-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68554-3025-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68554-3025-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68554-3025-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68554-3025-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68554-3025-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68554-3025-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68554-3025-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68554-3025-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68554-3025-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68554-3025-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68554-3025-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68554-3025-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68554-3025-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68554-3025-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68554-3025-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68554-3025-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68554-3025-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68554-3025-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68554-3025-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68554-3025-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68554-3025-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68554-3025-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68554-3025-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68554-3025-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68554-3025-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68554-3025-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68554-3025-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68554-3025-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68554-3025-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68554-3025-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68554-3025-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68554-3025-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68554-3025-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68554-3025-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68554-3025-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68554-3025-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68554-3025-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68554-3025-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68554-3025-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68554-3025-4ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090061-001FINASTERIDEFINASTERIDE5MGTABLET / ORALAB2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090061-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090061-001FINASTERIDE5MGTABLET / ORALAB2010-06-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090061-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090061-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090061-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090061-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090061-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090061-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090061-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090061-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090061-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090061-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090061-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090061-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090061-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090061-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090061-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090061-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090061-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090061-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090061-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090061-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090061-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090061-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090061-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090061-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090061-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090061-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090061-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090061-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090061-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090061-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090061-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090061-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090061-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090061-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090061-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090061-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090061-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090061-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090061-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090061-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68554-3025-02023-08-10These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-12023-08-10These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-22023-08-10These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-32023-08-10These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-42023-08-10These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-02020-01-31These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-12020-01-31These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-22020-01-31These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-32020-01-31These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992
68554-3025-42020-01-31These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinasterideFINASTERIDECardinal Health 107, LLC3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd042026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090061
application number: ANDA090061
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