Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200888
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;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
03/05/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

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

CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 021393 PFIZER
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 210676 AUROBINDO PHARMA LTD
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 090397 BIONPHARMA INC
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 200888 STRIDES PHARMA

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