CARBAMAZEPINE

Product NDC
51655-017
11-digit product format
516550017
Labeler code
51655
Product ID
51655-017_68b0341d-59e4-43c1-a1c4-71b7907d6e3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA075948
Marketing category
ANDA
Marketing start
2015-03-03
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-017DDiscontinued by firm2026-08-03
excluded packagepackage51655-01751655-017-92DDiscontinued by firm2026-08-03

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 · 44 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-017-92IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-017-92IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-017-92IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-017-92IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-017-92IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-017-92IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-017-92IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-017-92IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-017-92IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-017-92IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-017-92IInactivated by FDA367a005e9d99…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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated 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 packagepackage51655-017-92IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-017-92EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

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
A075948-001CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORALAB2002-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075948-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075948-001CARBAMAZEPINE200MGTABLET / ORALAB2002-02-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075948-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075948-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075948-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075948-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075948-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075948-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075948-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075948-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075948-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075948-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075948-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075948-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075948-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075948-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075948-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075948-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075948-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075948-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075948-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075948-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075948-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075948-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075948-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075948-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075948-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075948-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075948-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075948-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075948-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075948-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075948-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075948-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075948-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075948-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075948-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075948-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075948-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075948-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075948-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075948-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-017-922026-01-08C16284748780-19d75b9d0-e17f-f424-e053-dadaa90a57ceCARBAMAZEPINE
51655-017-922020-01-31C16284748780-19d75b9d0-e17f-f424-e053-dadaa90a57ceCARBAMAZEPINE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-017CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20150323_8e5df2e3-92fc-4865-97de-1da0a32c788d.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.52cf3ba9-0a7c-4809-830e-af93d15327262026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack34f57a68-57ad-57f1-e063-6394a90a3d332026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals Inc.32dc301e-881d-47b0-ad16-f9ff31d193242026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEGolden State Medical Supply, Inc.9fca7d59-dd9e-4fd8-bf34-e2f7e5a368012025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack45b355e6-9c19-4138-a1f8-53508e88f5a92025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CarbamazepineCARBAMAZEPINEAmerican Health Packaging1dd3d934-efee-4fdb-ae6f-f47b61831a2e2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEProficient Rx LPbf61798e-c07e-4959-909a-2b4c2c83b5322019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948
CARBAMAZEPINECARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLCc1fc31ef-6b2e-4de4-a185-ec44e94e7b402016-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075948
application number: ANDA075948