Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074265
Company: CHARTWELL RX

Products on ANDA 074265

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Discontinued	None	No	No
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Discontinued	None	No	No
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074265

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1994	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
01/27/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/2000	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/08/1997	SUPPL-11	Labeling		Label is not available on this site.
10/21/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/01/1997	SUPPL-9	Labeling		Label is not available on this site.
06/04/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-5	Labeling		Label is not available on this site.
03/13/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/02/1994	SUPPL-2	Labeling		Label is not available on this site.
08/01/1994	SUPPL-1	Labeling		Label is not available on this site.