Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078329
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription AB No No
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription AB No No
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription AB 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
02/05/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

IBUPROFEN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBU-TAB IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071058 ALRA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071334 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071267 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 204062 HEC PHARM
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 077114 PERRIGO R AND D
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA
IBUPROFEN IBUPROFEN 400MG TABLET;ORAL Prescription No AB 071644 VINTAGE PHARMS

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBU-TAB IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071059 ALRA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071335 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 204062 HEC PHARM
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 077114 PERRIGO R AND D
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 600MG TABLET;ORAL Prescription No AB 078329 STRIDES PHARMA

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 071935 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 078558 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 071268 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 072300 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 075682 DR REDDYS LA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 076112 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 091625 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 204062 HEC PHARM
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 090796 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 077114 PERRIGO R AND D
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 202413 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Prescription No AB 078329 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