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 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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12caaa826d4ba7…
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…

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 06:07:402026-07A075350-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075350-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075350-003AB1caaa826d4ba7…
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…

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
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
ndc (product): 72789-055
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 80425-0032
GabapentinGABAPENTINBryant Ranch Prepack77754734-4125-42b1-97c8-458bcab2bcf12024-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 71335-0351
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 71205-064
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 76420-014
ndc (product): 76420-015
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC37d4d465-19a5-46db-80dc-0b7334b3343a2018-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
ndc (product): 71610-072
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC86b30e64-fe56-42b3-a0f8-d9ef5d4b8c492016-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-3046GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3046GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4113GabapentinGabapentinNucare Pharmaceuticals,Inc.ANDACurrent
68071-4113GabapentinGabapentinNucare Pharmaceuticals,Inc.ANDACurrent
68071-4292GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4329GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4366GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4603GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68084-762GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-762GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-762GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-774GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-774GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-774GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-783GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-783GabapentinGabapentinAmerican Health PackagingANDACurrent
68084-783GabapentinGabapentinAmerican Health PackagingANDACurrent
68151-1030GabapentinGabapentinCarilion Materials ManagementANDACurrent
68788-6461GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7313GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7313GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7313GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7455GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7455GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7558GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7651GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7651GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0267GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0267GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0267GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0267GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0267GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0332GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0332GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0332GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0332GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0448GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
71205-064GabapentinGabapentinProficient Rx LPANDACurrent
71205-064GabapentinGabapentinProficient Rx LPANDACurrent
71205-064GabapentinGabapentinProficient Rx LPANDACurrent
71205-064GabapentinGabapentinProficient Rx LPANDACurrent
71335-0351GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0351GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0351GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0351GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0351GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0477GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0477GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0477GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0995GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0995GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-0995GabapentinGabapentinBryant Ranch PrepackANDACurrent
71610-072GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-055GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
76420-014GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
76420-014GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
76420-015GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
76420-015GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
80425-0032GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0032GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

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