An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076112
Company: DR REDDYS LABS INC

Products on ANDA 076112

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076112

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2001	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/76-112_Ibuprofen.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-18	Labeling-Package Insert, Labeling		Label is not available on this site.
04/28/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/11/2008	SUPPL-11	Labeling		Label is not available on this site.
03/31/2006	SUPPL-9	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076112

IBUPROFEN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Prescription	No	AB	214699	ALKEM LABS LTD
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	213794	AUROBINDO PHARMA LTD
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
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Prescription	No	AB	076112	DR REDDYS LABS INC
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Prescription	No	AB	091625	GRANULES
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Prescription	No	AB	090796	MARKSANS PHARMA
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	215318	YICHANG HUMANWELL

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	214699	ALKEM LABS LTD
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	213794	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	071268	CONTRACT PHARMACAL
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	075682	DR REDDYS
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	076112	DR REDDYS LABS INC
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	091625	GRANULES
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	090796	MARKSANS PHARMA
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	202413	SHANDONG XINHUA
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	078329	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Prescription	No	AB	215318	YICHANG HUMANWELL

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	214699	ALKEM LABS LTD
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	213794	AUROBINDO PHARMA LTD
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
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	076112	DR REDDYS LABS INC
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	091625	GRANULES
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	090796	MARKSANS PHARMA
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	202413	SHANDONG XINHUA
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	078329	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	No	AB	215318	YICHANG HUMANWELL

Top