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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040500
Company: PADAGIS ISRAEL

Products on ANDA 040500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY;RECTAL	Prescription	AB	No	No
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2003	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
06/09/2005	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040500

PROMETHAZINE HYDROCHLORIDE

SUPPOSITORY;RECTAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY;RECTAL	Prescription	No	AB	216446	ANNORA PHARMA
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040428	COSETTE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040500	PADAGIS ISRAEL

SUPPOSITORY;RECTAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY;RECTAL	Prescription	No	AB	216446	ANNORA PHARMA
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040428	COSETTE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY;RECTAL	Prescription	No	AB	040500	PADAGIS ISRAEL

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