Application 090007

Type
ANDA
Sponsor
MARKSANS PHARMA

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 43.

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
A090007-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2011-07-21
A090007-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2011-07-21
A090007-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090007-001AB
A090007-002AB
A090007-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090007-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090007-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090007-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090007-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090007-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090007-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001AB1301d65b070ca…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.9814b76c-87c6-4746-b712-3269352a901b2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 72789-123
GABAPENTINGABAPENTINREMEDYREPACK INC.915cee37-536c-4761-bdb9-b96c7ee0f9562026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 70518-2919
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 72189-113
ndc (product): 72189-109
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 80425-0079
GABAPENTINGABAPENTINBryant Ranch Prepackc33c4d83-cc13-4104-9e24-d4cd40b17b702024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 71335-1490
GABAPENTINGABAPENTINBryant Ranch Prepacke2d9bd8c-3bb9-4945-8e61-7d2703d9008c2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 71335-1991
GABAPENTINGABAPENTINBryant Ranch Prepack5769d849-4f27-4701-97ec-7e3ca07339d72024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 71335-2005
GABAPENTINGABAPENTINBryant Ranch Prepack78088f6a-06a3-422f-b336-4a57a24adc162024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 71335-0993
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.8f785189-bf66-36cc-e053-2a95a90a7cbc2024-06-19Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC9d1b9121-c25a-4d28-91c5-5fc72f1167f42018-07-12Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 71610-088
GabapentinGABAPENTINBi-Coastal Pharma International LLCe0cd96d1-b1ef-46ec-a5a3-9505b0811b8b2016-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 127 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7869GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7941GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7941GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
70518-2493GABAPENTINGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2493GABAPENTINGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2493GABAPENTINGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2919GABAPENTINGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-3103GABAPENTINGABAPENTINREMEDYREPACK INC.ANDACurrent
70934-284GABAPENTINGABAPENTINDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-651GABAPENTINGABAPENTINDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0993GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-0993GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-0993GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-1490GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-1490GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-1991GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-2005GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71610-088GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-195GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-195GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-109GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72189-113GABAPENTINGABAPENTINDIRECT RXANDACurrent
72789-123GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-123GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-123GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-123GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-123GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
80425-0079NeurontinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0079GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0079GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0079GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent