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 19 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINProficient Rx LP223a9216-6e07-49b9-8faf-bb4e529a6ae52022-04-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP2fb2233f-9152-4630-ab39-51a0cda7e5ca2022-04-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP52af51ab-6543-466b-848c-13c588c987892022-04-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP2b76955c-52a4-4026-b286-3da1112fe9892022-04-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
gabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7790d906-af26-4e60-bc6f-e906ec03cc242022-03-21Warnings, Adverse reactionsName fallback
brand name: gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC7f579665-afb7-4227-98c1-2eafee6505042022-02-28Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LP185f264e-db32-41cd-b90d-519717b978502021-11-01Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINAmneal Pharmaceuticals of New York LLCb11dbff5-ceee-4a63-a093-f6efebdc2f6f2021-02-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPf6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a2021-01-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc79d94ec-117d-4fb6-845d-1954e3472bb02021-01-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
Gaba 300-EZSGABAPENTINPureTek Corporationbb29692e-1546-4d05-a46a-93baf4172c7d2020-11-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC3b4395f2-9440-4b67-97cc-5d16f3bdd05e2020-08-14Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC39149f0e-30ed-4671-8be7-2a484f65d63b2020-08-05Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPded42b88-94dd-462d-bcdf-7fd34d1e49c32020-07-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP8b2f38ef-0a0c-45cc-88ca-cc086bf806412020-06-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCba2a8352-5776-4edb-914e-ce1d18ccda322020-05-27Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc09c66fd-cb31-41dd-b00b-acc58bd809f72020-01-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP7d77dae0-df76-4b7b-9690-713e9a60e3cd2019-12-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, 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.