Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050668
Company: KING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORABID LORACARBEF 200MG CAPSULE;ORAL Discontinued None No No
LORABID LORACARBEF 400MG CAPSULE;ORAL Discontinued None No No
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 3 - New Dosage Form 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
11/29/2000 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/11/2001 SUPPL-22 Labeling

Label is not available on this site.

11/08/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/18/1999 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/2000 SUPPL-19 Labeling

Label is not available on this site.

11/26/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/1996 SUPPL-16 Labeling

Label is not available on this site.

04/25/1996 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/13/1996 SUPPL-13 Efficacy-New Patient Population Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050667ap.pdf
01/25/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/05/1996 SUPPL-7 Labeling

Label is not available on this site.

09/22/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-3 Labeling

Label is not available on this site.

03/30/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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