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 5 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack53cad049-f1b4-42c0-9cc7-a1c2df75ac582024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackbd7393cb-2b72-4ecd-ba03-801b635b76472024-08-08Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack3c37d637-779d-4097-85ef-e4ce7d0fb86a2024-08-08Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack0ca26b58-0a93-4a10-be4d-63a4ad5eecf82024-06-06Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackac8559a0-98fe-4737-b9ec-e36eef3b14fc2024-04-08Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc5d60a6d-2410-4a3c-88e1-a6126b56cf6a2024-04-08Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.3b44d104-a7d0-4366-9d42-63f784f3cb222024-02-14Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack95f908c2-1003-4e8f-8e4a-86f4934568782024-01-15Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
LOMAIRAPHENTERMINE HYDROCHLORIDEKVK-TECH, INC.cde9fb09-e5af-434d-8874-e4f9f974d8932023-12-19Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack81751ece-8ccb-4aec-91ad-037c1d9fea532023-11-16Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack707af68e-1630-4f86-87ba-1a643d2b4ef92023-10-09Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack83802088-f4fc-4b34-9268-d63fb2ad16552023-09-27Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.22683183-a828-47a4-9e52-38175d7c6f212023-09-01Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb14a8f6a-a1c6-4104-80f2-0fa35320d04c2023-05-01Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.f938b0ab-606e-8b21-e053-6294a90a4f4c2023-04-13Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP5e1cc734-5d5c-429e-8b4c-4401a01cfba22023-04-01Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions8c7c1391-bfd1-48f9-b249-9729fe648b892023-02-04Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP28fda2ce-d445-47ce-8764-bf113b5db5b32022-11-01Warnings, 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