Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071107
Company: HIKMA INTL PHARMS

Products on ANDA 071107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	15MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/1986	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
01/17/2023	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
02/22/2019	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/18/2016	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2009	SUPPL-27	Labeling		Label is not available on this site.
08/20/2008	SUPPL-25	Labeling		Label is not available on this site.
11/30/2000	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
10/07/1999	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/01/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/06/1994	SUPPL-20	Labeling		Label is not available on this site.
05/31/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/24/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/24/1989	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/24/1989	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/01/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/13/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/12/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/12/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/12/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/12/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.