FDA.reportPublic FDA data

Application 087301

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDECAPSULE; ORAL15MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke08b4f49-de9f-490d-b11d-d865439f5fad2025-01-31Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack70f68311-8d1f-4b8e-b8a7-13bc4c17727e2025-01-31Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack86a6ce50-673d-4031-87a0-51965cc1e7952025-01-28Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke0a6a289-7dbf-4b24-b815-46dee0d19fdc2025-01-24Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack99c1325b-7152-481d-8a1f-6bf3e2c4808b2025-01-24Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack6b08ccd5-d01f-48f1-80a2-1d121f445d422025-01-23Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack5d84078d-ff2d-4800-b2f4-f1d30c8335bb2025-01-23Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxca683656-16a6-9602-e053-2a95a90aa8952025-01-20Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxd27d8379-aa3c-4688-e053-2995a90a44f62025-01-20Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.43024f64-2d77-49a9-80fd-ad07a86c69a32024-12-03Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack50efa498-11c5-41fa-95ac-419fcc10da032024-11-01Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc8516abe-5ad1-4b76-8e2c-96ee455979cf2024-10-17Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HCLPHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.8fe6b65d-ca61-40f0-90fc-255dfd0756112024-10-15Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1fa8798d-c096-5839-e063-6394a90aa28b2024-09-03Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack2bd5487d-10da-4ae0-9105-273e1a5efdcb2024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf427f067-f1a7-4d60-8ce0-90b20e2d4eb52024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf50f5453-e06d-4e39-b868-9bdadf1d8baa2024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22677ORIG1999-04-13