Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021855
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG CAPSULE;ORAL Over-the-counter None Yes No
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Over-the-counter None Yes 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
08/04/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021855ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021855s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2017 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021855Orig1s006ltr.pdf
12/11/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2017 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf
08/04/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.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.

CAPSULE;ORAL; 2MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Over-the-counter Yes 021855 BIONPHARMA INC

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

CAPSULE;ORAL; 1MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG CAPSULE;ORAL Over-the-counter Yes 021855 BIONPHARMA INC

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