Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040151
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;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
08/26/1997 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
06/28/2018 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/19/2018 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/29/2017 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/29/2017 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/13/2017 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/26/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/09/2009 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/19/2008 SUPPL-7 Labeling

Label is not available on this site.

02/25/2008 SUPPL-6 Labeling

Label is not available on this site.

02/04/2008 SUPPL-3 Labeling

Label is not available on this site.

02/17/2006 SUPPL-2 Labeling

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

SYRUP;ORAL; 10MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088763 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200894 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040151 HI TECH PHARMA
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 090180 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200386 TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088875 WOCKHARDT BIO AG
PROMETHAZINE WITH CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040650 VINTAGE

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