Application 075350

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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 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
A075350-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2003-09-12
A075350-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2003-09-12
A075350-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2003-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075350-001AB
A075350-002AB
A075350-003AB

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 UTC2026-02A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-128072bd15b7f6…

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 UTC2026-02A075350-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075350-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075350-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075350-001AB18072bd15b7f6…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINTeva Pharmaceuticals, Inc.c7f21eaa-68ee-420c-9c98-e997cc73a2972026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.b4c7388a-19d9-4e3a-83c9-4943fb855be42025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 45963-556
ndc (product): 45963-555
ndc (product): 45963-557
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINBryant Ranch Prepack77754734-4125-42b1-97c8-458bcab2bcf12024-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 63187-988
Gaba 300-EZSGABAPENTINPureTek Corporationbb29692e-1546-4d05-a46a-93baf4172c7d2020-11-16Warnings, Adverse reactionsExact identifier
ndc (product): 59088-725
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC37d4d465-19a5-46db-80dc-0b7334b3343a2018-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC86b30e64-fe56-42b3-a0f8-d9ef5d4b8c492016-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 43353-075
ndc (product): 43353-081

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 146 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1376GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1377GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1378GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7762GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7839GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7844GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7845GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42495-556GabapentinGabapentinWestwood ManufacturingANDACurrent
43353-075GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-081GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
50090-2561GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3318GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-5550GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-5550GabapentinGabapentinUnit Dose ServicesANDACurrent
53002-3423GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
53002-4423GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
55154-4691GabapentinGabapentinCardinal HealthANDACurrent
55154-4691GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55695-017GabapentinGabapentinDepartment of State Health Services, Pharmacy BranchANDACurrent
59088-725Gaba 300-EZSGabapentinPureTek CorporationANDACurrent
60760-557GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
61786-469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
61919-083GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-252GABAPENTINGABAPENTINDirectRXANDACurrent
61919-252GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-252GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
64725-0511GabapentinGabapentinTYA PharmaceuticalsANDACurrent
66116-358GabapentinGabapentinMedVantx, Inc.ANDACurrent
67046-703GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67544-353GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-354GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-361GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-1995GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3046GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24152ORIG2008-02-01
22462ORIG2007-07-06