FDA.reportPublic FDA data

Application 020951

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAGAMET HB 200CIMETIDINESUSPENSION;ORAL200MG/20MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020951-001TAGAMET HB 200CIMETIDINE200MG/20MLSUSPENSION / ORAL1999-07-09

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020951-001TAGAMET HB 200200MG/20MLSUSPENSION / ORAL1999-07-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020951-001TAGAMET HB 200200MG/20MLSUSPENSION / ORAL1999-07-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020951-001TAGAMET HB 200200MG/20MLSUSPENSION / ORAL1999-07-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020951-001TAGAMET HB 200200MG/20MLSUSPENSION / ORAL1999-07-09a50c72e98297…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerCIMETIDINEAmazon.com Services LLC81dbc581-aa51-46bf-8b69-6d926de2f5832026-08-18WarningsName fallback
generic name: CIMETIDINE
CimetidineCIMETIDINEMylan Pharmaceuticals Inc.06c0a509-026f-44e0-9975-a94a8de51d432026-07-15Adverse reactionsName fallback
generic name: CIMETIDINE
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
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
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21299ORIG2000-05-18
26287ORIG1999-07-09
13809ORIG1999-07-09