FDA.reportPublic FDA data

Application 017352

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FASTINPHENTERMINE HYDROCHLORIDECAPSULE;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017352-001FASTINPHENTERMINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982

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2026-08-01 22:54:322026-06N017352-001FASTIN30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982a50c72e98297…

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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC5528d9f7-45ad-d323-e063-6394a90a3e092026-06-25Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEAurolife Pharma LLC5927e0f6-3de3-4885-a633-5b92003f6fe42026-06-10Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.19f1ce79-65f4-4bf4-a9ff-6ca0a131530f2026-06-02Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.130e6087-0ab6-4456-a781-d370f363dc382026-06-01Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
LOMAIRAPHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.0718f0f3-77f2-45d7-be12-1ed718c8b8062026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.d24aaa53-9c78-4c1b-9495-c785a9cf2b262026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2f3b738f-d66b-40c1-8e69-bcd50bce3e472026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
PhenterminePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.27e88ebe-6247-4598-8ef2-c882992ed5792026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.3d1d4dde-1c7f-4a20-b8f8-897b1b284f802026-05-21Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke6939fcf-3db2-492a-99ed-a384cdeea7a22026-05-11Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.eae1d7f9-733c-434b-9199-5f7052e541da2026-04-14Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack328d6a39-34f4-4b74-a1bf-6ec6005b13222026-04-01Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b425840f-380e-42bd-852a-6ee3641977ce2026-03-23Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke48feec6-50c9-4ccd-b9da-56956d14c8532026-03-18Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack9155edf8-ea1d-458f-b2a7-e0303fd83cc02026-03-16Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b2026-03-04Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfa5de92d-a5bf-4ae1-8e13-ad827aeebea32026-02-04Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions86ec6b9d-2934-4bad-8a80-0b60e2f912f32026-01-24Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE