Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062927
Company: DAVA PHARMS INC

Products on ANDA 062927

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	125MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
AMOXICILLIN	AMOXICILLIN	250MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/1988	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
04/23/2024	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
04/23/2024	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
04/23/2024	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
11/30/2001	SUPPL-16	Labeling		Label is not available on this site.
07/13/2001	SUPPL-15	Labeling		Label is not available on this site.
09/05/2001	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2001	SUPPL-13	Labeling		Label is not available on this site.
11/27/2000	SUPPL-12	Labeling		Label is not available on this site.
11/17/1999	SUPPL-10	Labeling		Label is not available on this site.
01/25/1999	SUPPL-9	Labeling		Label is not available on this site.
06/09/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/14/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/02/1994	SUPPL-6	Labeling		Label is not available on this site.
06/02/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/17/1992	SUPPL-3	Labeling		Label is not available on this site.
11/17/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.