Application 078428

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

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
A078428-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2007-07-25
A078428-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2007-07-25
A078428-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2007-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078428-001AB
A078428-002AB
A078428-003AB

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 06:07:402026-07A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-002GABAPENTIN300MGCAPSULE / ORALAB2007-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-003GABAPENTIN400MGCAPSULE / ORALAB2007-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078428-001GABAPENTIN100MGCAPSULE / ORALAB2007-07-251e350fbaab3a…

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 06:07:402026-07A078428-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078428-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078428-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078428-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078428-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078428-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078428-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078428-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078428-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078428-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078428-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078428-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078428-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078428-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078428-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078428-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078428-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078428-001AB11e350fbaab3a…

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
GabapentinGABAPENTINUnit Dose Solutions, Inc.54dc347e-cba0-ea73-e063-6294a90ab4362026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINAmneal Pharmaceuticals LLC507bf6d0-e7a2-413d-9848-cd2445a1411d2026-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack7b404ab9-8a7e-49d4-920f-487875d14e452024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack657349fb-41a9-4814-b4ac-4c5afbdde9472024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepacka15d5dcc-63c4-4c06-ab91-5e22cdf234cc2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack477691f5-0591-4544-840a-ac590e1f25a12024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINBryant Ranch Prepack506bf880-9564-404c-951a-703797ffdad82024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
ndc (product): 63629-7306
GabapentinGABAPENTINClinical Solutions Wholesale, LLCdbedccfb-0e27-4119-93b9-241c039e045a2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
GabapentinGABAPENTINAmneal Pharmaceuticals of New York LLCb11dbff5-ceee-4a63-a093-f6efebdc2f6f2021-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078428
application number: ANDA078428
ndc (product): 53746-102
ndc (product): 53746-103
ndc (product): 53746-101

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 126 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7559GabapentinGabapentinLiberty Pharmaceuticals, Inc.ANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-186GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
33261-048GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33261-049GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33261-050GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33358-153GabapentinGabapentinRxChange Co.ANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-103GabapentinGabapentinRebel Distributors CorpANDACurrent
42254-112GabapentinGabapentinRebel Distributors CorpANDACurrent
42291-300GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKAREANDACurrent
45865-347GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
50090-3353GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-7284GabapentinGabapentinUnit Dose ServicesANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55700-276GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-277GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7962GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7962GabapentinGabapentinBryant Ranch PrepackANDACurrent
63739-236GabapentinGabapentinMcKesson CorporationANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-591GabapentinGabapentinMcKesson CorporationANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-675GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-675GabapentinGabapentinMcKesson CorporationANDACurrent
63739-689GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-689GabapentinGabapentinMcKesson CorporationANDACurrent
63739-693GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-693GabapentinGabapentinMcKesson CorporationANDACurrent
63739-984GabapentinGabapentinMcKesson CorporationANDACurrent
63739-984GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-984GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent