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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050667
Company: KING PHARMS

Products on NDA 050667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORABID	LORACARBEF	100MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
LORABID	LORACARBEF	200MG/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1991	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2001	SUPPL-22	Labeling		Label is not available on this site.
09/12/2000	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/11/2001	SUPPL-20	Labeling		Label is not available on this site.
11/08/1999	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/05/2000	SUPPL-18	Labeling		Label is not available on this site.
11/12/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/26/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/01/1997	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
07/09/1996	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/1996	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/13/1996	SUPPL-11	Efficacy-New Patient Population	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050667ap.pdf
02/21/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/08/1995	SUPPL-9	Labeling		Label is not available on this site.
02/08/1995	SUPPL-8	Labeling		Label is not available on this site.
06/24/1994	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/1993	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/02/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/16/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/30/1992	SUPPL-2	Labeling		Label is not available on this site.

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