Adoxa

Product NDC
10337-815
11-digit product format
103370815
Labeler code
10337
Product ID
10337-815_26b9e8bd-a1aa-4293-aacc-927cc75149c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application
ANDA065055
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10337-815DDiscontinued by firm2026-09-14
excluded packagepackage10337-81510337-815-06DDiscontinued by firm2026-09-14

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 1 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10337-815-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10337-815-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10337-815-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10337-815-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10337-815-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10337-815-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10337-815-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10337-815-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10337-815-06DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10337-815-06DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10337-815-06DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10337-815-06IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10337-815-06IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10337-815-06IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10337-815-06IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10337-815-06IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10337-815-06IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10337-815-06IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10337-815-06IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10337-815-06IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10337-815-06IInactivated by FDA9bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1584e616aacf4f…
2026-09-14 22:38:342026-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1884e616aacf4f…
2026-08-18 06:07:402026-07A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065055-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065055-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A065055-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A065055-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065055-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-001AB1301d65b070ca…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10337-815-062024-08-26C16284748780-19d75b9d0-3c22-f424-e053-dadaa90a57ceADOXA ® DOXYCYCLINE CAPSULES, USP
10337-815-062020-01-31C16284748780-19d75b9d0-3c22-f424-e053-dadaa90a57ceADOXA ® DOXYCYCLINE CAPSULES, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-815-06EA - Each10337-81520cd52a3-876f-400b-ab59-9ea3e00c350712013-06-04

DailyMed Socrata Ingredients#

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055