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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074978
Company: ACTAVIS MID ATLANTIC

Products on ANDA 074978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1998	ORIG-1	Approval			Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74978ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-53	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/28/2021	SUPPL-49	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-48	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
06/03/2010	SUPPL-30	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/074978Orig1s030ltr.pdf
07/31/2008	SUPPL-28	Labeling		Label is not available on this site.
10/29/2003	SUPPL-10	Labeling		Label is not available on this site.
10/25/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/29/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/2000	SUPPL-4	Labeling		Label is not available on this site.
11/19/1999	SUPPL-3	Labeling		Label is not available on this site.
11/19/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074978

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 074978

IBUPROFEN

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	074978	ACTAVIS MID ATLANTIC
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209178	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	076925	PADAGIS US
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215311	STRIDES PHARMA
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209204	SUN PHARMA CANADA

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