Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070664
Company: CHARTWELL RX

Products on ANDA 070664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/1986	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
05/09/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
05/18/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/22/1992	SUPPL-13	Labeling		Label is not available on this site.
07/10/1989	SUPPL-12	Labeling		Label is not available on this site.
11/29/1988	SUPPL-11	Labeling		Label is not available on this site.
12/22/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/22/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/11/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/31/1987	SUPPL-7	Labeling		Label is not available on this site.
12/22/1988	SUPPL-6	Labeling		Label is not available on this site.
12/22/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/22/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/18/1986	SUPPL-3	Labeling		Label is not available on this site.
11/19/1986	SUPPL-2	Labeling		Label is not available on this site.
02/05/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.