Home Applications 087301 Application 087301
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL 15MG No No
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 6 of 6 · 109 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE Proficient Rx LP b3c48b3c-fab7-4ea4-93b0-b108979e9da3 2022-04-01 Warnings, Adverse reactions Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE Proficient Rx LP 5c1f88ba-d7d6-4b48-b951-c5e65d87e874 2022-03-01 Warnings, Adverse reactions Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE Asclemed USA, Inc. de76ed27-ac43-4923-b73f-461d33941f6b 2020-10-30 Warnings, Adverse reactions Name fallback brand name: Phentermine hydrochloride generic name: PHENTERMINE HYDROCHLORIDE Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE Proficient Rx LP 3a3259ec-ded3-427f-843d-928d130de3da 2020-03-01 Adverse reactions Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE Epic Pharma, LLC 06573bd8-67b4-4478-8325-aa6be25787cb 2019-11-22 Warnings, Adverse reactions Name fallback brand name: PHENTERMINE HYDROCHLORIDE generic name: PHENTERMINE HYDROCHLORIDE Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE Proficient Rx LP f2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e 2019-11-01 Warnings, Adverse reactions Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE Phentermine PHENTERMINE HYDROCHLORIDE Aurolife Pharma, LLC 737eef3b-9a6b-4ab3-a25c-49d84d2a0197 2019-01-04 Warnings, Adverse reactions Name fallback generic name: PHENTERMINE HYDROCHLORIDE Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE KVK-TECH, Inc. ff620c0b-aa99-4f63-9526-d094cedc8d19 2018-12-20 Warnings, Adverse reactions Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE Elite Laboratories, Inc. 0b7ad9c0-9e1e-4a69-802b-28f44267e34d 2017-04-14 Warnings, Adverse reactions Name 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 Document Submission type Date 22677 ORIG 1999-04-13