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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072300
Company: CONTRACT PHARMACAL

Products on ANDA 072300

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072300

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/1988	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-2	Labeling-Package Insert		Label is not available on this site.
01/23/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072300

IBUPROFEN

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

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