Application 075360

Type
ANDA
Sponsor
GRANULES INDIA LTD

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
A075360-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2005-04-06
A075360-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2005-04-06
A075360-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075360-001AB
A075360-002AB
A075360-003AB

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 06:07:402026-07A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-061e350fbaab3a…

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 06:07:402026-07A075360-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075360-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075360-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075360-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075360-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075360-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075360-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075360-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075360-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075360-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075360-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075360-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075360-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075360-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075360-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075360-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075360-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075360-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075360-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075360-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-001AB11e350fbaab3a…

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
GABAPENTINGABAPENTINGranules Pharmaceuticals Incc681c804-c6f3-d63b-e053-2995a90a6b8f2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 70010-927
ndc (product): 70010-926
ndc (product): 70010-928
GABAPENTINGABAPENTINBryant Ranch Prepack397fd6d3-317b-4b61-a52b-3a09ca1d88a42026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 71335-1997
GABAPENTINGABAPENTINBryant Ranch Prepack13640281-26b4-402e-8f69-7c81cd6e03762026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 71335-2004
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY3aaf3d6e-c6d5-89f5-e063-6394a90a9b772025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.b20ee34a-7f2d-4d62-a161-898565f745472025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 70010-118
ndc (product): 70010-108
ndc (product): 70010-109
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc859e666-d510-426b-e053-2995a90a9a3c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 80425-0150
GABAPENTINGABAPENTINAsclemed USA, Inc.5fb79774-c2d4-47ba-9a16-eb367d0fdcff2023-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 71205-661
GABAPENTINGABAPENTINProficient Rx LP185f264e-db32-41cd-b90d-519717b978502021-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
ndc (product): 71205-619

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5631GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-5632GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-5633GabapentinGabapentinMajor PharmaceuticalsANDACurrent
10544-436GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
10544-447GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
21695-055GabapentinGabapentinRebel Distributors Corp.ANDACurrent
21695-056GabapentinGabapentinRebel Distributors Corp.ANDACurrent
21695-344GabapentinGabapentinRebel Distributors Corp.ANDACurrent
50090-1681GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2590GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2794GabapentinGabapentinA-S Medication SolutionsANDACurrent
55154-1379GabapentinGabapentinCardinal HealthANDACurrent
55700-299GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
60505-0112GabapentinGabapentinApotex Corp.ANDACurrent
60505-0112GabapentinGabapentinApotex Corp.ANDACurrent
60505-0112GabapentinGabapentinApotex Corp.ANDACurrent
60505-0112GabapentinGabapentinApotex Corp.ANDACurrent
60505-0112GabapentinGabapentinApotex Corp.ANDACurrent
60505-0113GabapentinGabapentinApotex Corp.ANDACurrent
60505-0113GabapentinGabapentinApotex Corp.ANDACurrent
60505-0113GabapentinGabapentinApotex Corp.ANDACurrent
60505-0113GabapentinGabapentinApotex Corp.ANDACurrent
60505-0113GabapentinGabapentinApotex Corp.ANDACurrent
60505-0114GabapentinGabapentinApotex Corp.ANDACurrent
60505-0114GabapentinGabapentinApotex Corp.ANDACurrent
60505-0114GabapentinGabapentinApotex Corp.ANDACurrent
60505-0114GabapentinGabapentinApotex Corp.ANDACurrent
60505-0114GabapentinGabapentinApotex Corp.ANDACurrent
62207-922GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-922GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-923GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-923GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-924GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-924GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-926GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-926GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-927GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-927GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-928GABAPENTINGABAPENTINGranules India LimitedANDACurrent
62207-928GABAPENTINGABAPENTINGranules India LimitedANDACurrent
63629-6983GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6983GabapentinGabapentinBryant Ranch PrepackANDACurrent
68151-1028GabapentinGabapentinCarilion Materials ManagementANDACurrent
68788-8176GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
70010-108GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-108GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-109GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-109GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-118GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-118GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.ANDACurrent
70010-926GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
70010-926GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
70010-927GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
70010-927GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
70010-928GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
70010-928GABAPENTINGABAPENTINGranules Pharmaceuticals IncANDACurrent
71205-619GABAPENTINGABAPENTINProficient Rx LPANDACurrent
71205-661GABAPENTINGABAPENTINProficient Rx LPANDACurrent
71335-1997GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-1997GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-2004GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
71335-2004GABAPENTINGABAPENTINBryant Ranch PrepackANDACurrent
80425-0150NeurontinGabapentin 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0150NeurontinGabapentin 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0150GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0150GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0150GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42984ORIG2007-07-06