Drugs@FDA: FDA Approved Drug Products

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