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 2 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfa5de92d-a5bf-4ae1-8e13-ad827aeebea32026-02-04Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions86ec6b9d-2934-4bad-8a80-0b60e2f912f32026-01-24Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsea798229-fc2d-417c-9bc9-a3b942f0b64b2026-01-23Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions0e893b62-bb07-4984-9f0a-3601435fbc272026-01-22Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1149f69d-65df-6a98-e063-6394a90aeaa42026-01-22Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack4686bc8d-7173-477e-96c8-a7d33653df2e2026-01-07Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd76940d3-95e6-442d-99ef-4fe92de7a3762025-12-29Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC1b5396a8-e7ef-45ae-e063-6294a90a14a22025-12-26Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDETAGI Pharma, Inc.1993b181-f4f1-4451-92a0-7ed8f32598ba2025-12-23Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPrecision Dose Inc.8d5697b9-02e8-40c4-97c7-761d635243c82025-12-16Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPrecision Dose Inc.095a2be5-721e-46e6-976f-9137c855cd222025-12-02Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka9270c14-499f-4c07-a1eb-c0aab5d8731f2025-10-29Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6749c074-52a1-4d74-96a2-d9302b3c49a12025-10-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68fcc228-5f06-4ece-94f3-59b5b33c33252025-10-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4000c00f-aa6c-4ea5-af0e-149dde3c74db2025-10-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f115ad6d-cf62-40e7-89d1-6183a9b5071f2025-10-17Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.378d863a-6977-4543-ae50-c3684a6abd9b2025-10-15Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abf702d6-6f94-48dc-ad23-c52fd74e83a82025-10-15Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2abc445c-daa8-7326-e054-00144ff88e882025-10-15Warnings, 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