FDA.reportPublic FDA data

Application 017920

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002TAGAMETCIMETIDINETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
003TAGAMETCIMETIDINETABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
004TAGAMETCIMETIDINETABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
005TAGAMETCIMETIDINETABLET;ORAL800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017920-002TAGAMETCIMETIDINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017920-003TAGAMETCIMETIDINE300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017920-004TAGAMETCIMETIDINE400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1983-12-14
N017920-005TAGAMETCIMETIDINE800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-30

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 22:54:322026-06N017920-002TAGAMET200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017920-003TAGAMET300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N017920-004TAGAMET400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1983-12-14a50c72e98297…
2026-08-01 22:54:322026-06N017920-005TAGAMET800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-30a50c72e98297…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACID CONTROLLERCIMETIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDcf772ee0-680a-4e1c-8c5d-929756896b362026-05-11WarningsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEBryant Ranch Prepack0ab5ea2b-bd2f-49ec-9e92-033bed9987972026-03-09Adverse reactionsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINENorthwind Health Company, LLCdb482bd8-e68d-3a38-e053-2995a90a38a52026-01-01Adverse reactionsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEPD-Rx Pharmaceuticals, Inc.28fd7158-a617-436a-8f5c-71ffbaafe5272025-10-20Adverse reactionsName fallback
generic name: CIMETIDINE
heartburn preventionCIMETIDINEH E Bf7156440-f2d8-4292-a436-388622ff39652025-08-26WarningsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEA-S Medication Solutions28fa98b3-6c78-4b7b-9a37-84c879dbf58a2025-05-02Adverse reactionsName fallback
generic name: CIMETIDINE
cimetidine 200 acid reducerCIMETIDINEWalgreen Company7087f4bb-992b-4680-a9a7-452ce74eed2d2025-03-10WarningsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEBionpharma Inc.2d7b6e7d-cf01-70a2-e063-6394a90afbe62025-02-20Adverse reactionsName fallback
generic name: CIMETIDINE
CIMETIDINECIMETIDINEAurobindo Pharma Limitedebd53065-c080-4045-a398-64d3f3b1460f2024-11-14Adverse reactionsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEA-S Medication Solutionscf1626a1-ccf6-4759-b2ab-22c7f3873d842024-11-08Adverse reactionsName fallback
generic name: CIMETIDINE
TagametCIMETIDINEMedtech Products Inc.e6401e0a-8612-42e8-bf89-2d67243f28dc2024-06-10WarningsName fallback
brand name: Tagamet
generic name: CIMETIDINE
CimetidineCIMETIDINEProficient Rx LP5c2e1f52-4021-4f70-9b2b-63af170941872024-04-01Adverse reactionsName fallback
generic name: CIMETIDINE
CIMETIDINECIMETIDINEChartwell RX, LLC01997826-7ca1-473e-bfc9-075b14b58a352023-08-18Adverse reactionsName fallback
generic name: CIMETIDINE
TAGAMETCIMETIDINEPrestige Brands Holdings, Inc.c8ba8815-9d99-439f-b397-3869f729d9f42023-01-20WarningsName fallback
brand name: TAGAMET
generic name: CIMETIDINE
CimetidineCIMETIDINETeva Pharmaceuticals USA, Inc.496e258d-a5fd-42da-9a86-73afc8be359b2022-11-30Adverse reactionsName fallback
generic name: CIMETIDINE
Equate CimetidineCIMETIDINEWal-Mart Stores Incad3e8f6a-8e35-42c2-a98c-566a2868e9232022-03-10WarningsName fallback
generic name: CIMETIDINE
basic care acid reducerCIMETIDINEAmazon.com Services LLCffba8756-b9de-4d18-85fa-b4dd25d2cb4c2022-01-14WarningsName fallback
generic name: CIMETIDINE
heartburn reliefCIMETIDINECVS Pharmacy464b1dec-3220-471c-b067-a06a87fb8cae2022-01-05WarningsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEMylan Pharmaceuticals Inc.06c0a509-026f-44e0-9975-a94a8de51d432019-08-15Adverse reactionsName fallback
generic name: CIMETIDINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
747SUPPL2006-07-21
13953SUPPL2005-12-16