Application 078069

Type
ANDA
Sponsor
BRECKENRIDGE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

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
A078069-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2008-01-11
A078069-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2008-01-11
A078069-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2008-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078069-001AB
A078069-002AB
A078069-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078069-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078069-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078069-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078069-001AB18072bd15b7f6…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ffc8d10c-0049-4fe5-beb8-79cc6a197ede2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 70518-2370
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 70518-2253
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.85a9bdee-4d10-4097-ae3d-0bf8d844a11b2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticalsb1d54def-057d-4608-bc8f-1d967ac3ec912026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 0904-7262
ndc (product): 0904-7263
ndc (product): 0904-7264
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.fcf5044a-8cfd-47d5-9f47-8f6674843c242026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticals567c0777-9bc5-45a9-ba25-959dd76d0e052026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.54fb494e-bce4-442d-954a-757f9851e81e2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.244f9a68-5ab4-46b8-a01f-538572fd3c5f2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 70518-2254
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 70518-2276
OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.b9db5c45-8b51-449b-b4af-1a235c08f1892025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 60429-063
ndc (product): 60429-061
ndc (product): 60429-062
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.a1b6a698-f7d9-4adb-9e38-b63e7a85e2b32025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.1176d5f5-3447-4925-aed8-1a1cb4b5989d2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINECoupler LLC3f15c889-4386-850b-e063-6294a90a8dbf2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.e156339c-f79e-4a20-b9da-f50bea9482132025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 68788-7866
OXCARBAZEPINEOXCARBAZEPINECardinal Health 107, LLC4ebcb0e5-1c93-4b3f-8749-6835c56afce52025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack38694974-3dc6-42b5-bdf9-b5354e35330b2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd8edaa2b-3bab-4030-a4e3-0c77f76557312024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack78f196d4-110e-45b1-813a-725f52c1a4eb2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 63629-3816
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd3c7a3b8-b9a2-4a5f-98b3-0ed02eca34332024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 63629-6834
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack255f64ba-7667-48e6-8599-3b598bf6f4e92024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 63629-9186

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7262OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
0904-7263OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
0904-7264OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
50090-5003OXCARBAZEPINEOXCARBAZEPINEA-S Medication SolutionsANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal Health 107, LLCANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55154-8198OxcarbazepineOxcarbazepineCardinal Health 107, LLCANDACurrent
55154-8198OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55700-868OXCARBAZEPINEOXCARBAZEPINEQuality Care Products, LLCANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
63629-2075OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-2075OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-9186OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
64725-0292OXCARBAZEPINEOXCARBAZEPINETYA PharmaceuticalsANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68788-7866OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7866OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2370OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22619ORIG2011-02-15
44630ORIG2008-01-17