Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214039
Company: GRANULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter 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
02/23/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 250MG;250MG;65MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 214039 GRANULES
ACETAMINOPHEN, ASPIRIN AND CAFFEINE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter No 075794 PERRIGO
EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250MG;250MG;65MG TABLET;ORAL Over-the-counter Yes 020802 GLAXOSMITHKLINE CONS

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