FDA.reportPublic FDA data

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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06a50c72e98297…
2026-08-01 22:54:322026-06A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06a50c72e98297…
2026-08-01 22:54:322026-06A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075360-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075360-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075360-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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