Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083564
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/1975 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083564_delcobese_toc.cfm

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English