Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073399
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEMASTINE FUMARATE CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/30/1994 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
08/30/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

12/09/1999 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/30/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/15/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/02/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/29/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/29/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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