Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074512
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEMASTINE FUMARATE CLEMASTINE FUMARATE 1.34MG TABLET;ORAL Over-the-counter 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
11/22/1995 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
12/13/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

11/21/2002 SUPPL-6 Labeling

Label is not available on this site.

03/23/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-3 Labeling

Label is not available on this site.

07/09/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLEMASTINE FUMARATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 1.34MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLEMASTINE FUMARATE CLEMASTINE FUMARATE 1.34MG TABLET;ORAL Over-the-counter No 074512 L PERRIGO CO

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