Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080927
Company: HIKMA

Products on ANDA 080927

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPANTHELINE BROMIDE	PROPANTHELINE BROMIDE	7.5MG	TABLET;ORAL	Discontinued	None	No	No
PROPANTHELINE BROMIDE	PROPANTHELINE BROMIDE	15MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1974	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
02/07/2000	SUPPL-39	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/12/1999	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
02/27/1992	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
02/27/1992	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
06/20/1991	SUPPL-34	Labeling		Label is not available on this site.
03/18/1991	SUPPL-33	Labeling		Label is not available on this site.
10/04/1991	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
10/04/1991	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
10/04/1991	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
11/13/1989	SUPPL-28	Labeling		Label is not available on this site.
09/11/1989	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/25/1986	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.