Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040026
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 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
09/25/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40026ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2009 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/22/2007 SUPPL-6 Labeling

Label is not available on this site.

06/12/2006 SUPPL-5 Labeling

Label is not available on this site.

04/03/2006 SUPPL-4 Labeling

Label is not available on this site.

07/27/2005 SUPPL-3 Labeling

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040882 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040026 HI TECH PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040891 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040718 TARO
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 091675 TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040643 VINTAGE
PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 087953 WOCKHARDT BIO AG

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