FDA.reportPublic FDA data

Application 203611

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET; ORAL300MGNoNo
002GABAPENTINGABAPENTINTABLET; ORAL600MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203611-001GABAPENTINGABAPENTIN300MGTABLET / ORALAB22026-06-23
A203611-002GABAPENTINGABAPENTIN600MGTABLET / ORALAB22026-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203611-001AB2
A203611-002AB2

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
2026-09-14 22:38:342026-08A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-23caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203611-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A203611-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07A203611-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203611-002AB21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-001AB21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-002AB21a50c72e98297…

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 16 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINDirect_Rxfbc05ceb-2e69-3c37-e053-6394a90ac4f42024-09-06Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack2dad630a-09d8-4f40-bdad-24e877a9ee382024-09-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC26aac429-a5cd-33cc-e063-6394a90aecc02024-09-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC266ef369-0a56-f225-e063-6294a90a495e2024-09-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBoswell Pharmacy Services LLC d/b/a BPS Wholesale1e28ad3d-2d34-a5d0-e063-6294a90adb9e2024-07-26Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9c99dfa-f54d-9207-e053-2995a90ad43b2024-07-17Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9f0852e-0c58-ba22-e053-2995a90adfa02024-07-17Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb2024-07-08Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.8f785189-bf66-36cc-e053-2a95a90a7cbc2024-06-19Name fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.8e6ed5d2-40e0-1f06-e053-2a95a90aa40e2024-06-18Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Name fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackffe5321d-3405-46d5-a75f-c51e8f8d87b12024-05-29Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINClinical Solutions Wholesale, LLC934fefae-b895-427c-8798-4c5462b1ecc22024-04-11Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ed219efc-84e3-5bdc-e053-2a95a90a56fc2024-04-11Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINClinical Solutions Wholesale, LLCdbedccfb-0e27-4119-93b9-241c039e045a2024-04-10Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack47f2a06f-4eac-4dca-aa2a-a36dd4daaea02024-04-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack38210141-bbdc-4186-b71f-54c72f794dca2024-04-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack75418d32-6504-4cb4-b3a9-afa0eaf19b8d2024-04-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack1ec656c9-034f-4f14-9e6b-9779d41e16272024-04-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack8de89818-805a-4a20-a9b1-48cf443b63152024-04-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

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