Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075232
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter 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
01/06/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2007 SUPPL-20 Labeling

Label is not available on this site.

10/04/2002 SUPPL-6 Labeling

Label is not available on this site.

10/04/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/2002 SUPPL-4 Labeling

Label is not available on this site.

10/04/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/06/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide_prntlbl.pdf

LOPERAMIDE HYDROCHLORIDE

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

TABLET;ORAL; 2MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter Yes 019860 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 206548 AUROBINDO PHARMA LTD
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 075232 L PERRIGO CO
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 076497 LNK
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 074091 OHM LABS

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