Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213070
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;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
08/11/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213070Orig1s000ltr.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
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Over-the-counter No 213070 STRIDES PHARMA

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