Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090180
Company: NOSTRUM LABS INC

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
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 10MG; 5ML SYRUP; ORAL Prescription 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
03/17/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090180s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
08/29/2017 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/13/2017 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/10/2013 SUPPL-5 Labeling-Package Insert

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 Yes AA 088763 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040151 AKORN
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 090180 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 214238 QUAGEN
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 PHARM ASSOC

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE

There are no Therapeutic Equivalents.

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