Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040331
Company: EPIC PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AA No No
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AA 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
05/28/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40331ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-16 REMS - PROPOSAL - D-N-A

Label is not available on this site.

10/21/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/31/2012 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/17/2004 SUPPL-6 Labeling

Label is not available on this site.

09/07/2004 SUPPL-4 Labeling

Label is not available on this site.

06/03/2004 SUPPL-3 Labeling

Label is not available on this site.

MEPERIDINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 040331 EPIC PHARMA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 040446 SUN PHARM INDS INC
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 040191 VINTAGE PHARMS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 040110 WEST-WARD PHARMS INT

TABLET;ORAL; 100MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040331 EPIC PHARMA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040446 SUN PHARM INDS INC
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040191 VINTAGE PHARMS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AA 040110 WEST-WARD PHARMS INT

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