An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040428
Company: COSETTE

Products on ANDA 040428

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040428.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2016	SUPPL-31	Labeling-Container/Carton Labels		Label is not available on this site.
12/18/2012	SUPPL-26	Labeling		Label is not available on this site.
12/18/2012	SUPPL-25	Labeling-Container/Carton Labels		Label is not available on this site.
05/26/2010	SUPPL-24	Labeling-Container/Carton Labels		Label is not available on this site.
04/26/2010	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
10/13/2005	SUPPL-19	Labeling		Label is not available on this site.
10/06/2004	SUPPL-8	Labeling		Label is not available on this site.
06/18/2004	SUPPL-5	Labeling		Label is not available on this site.
03/31/2003	SUPPL-4	Labeling		Label is not available on this site.
03/31/2003	SUPPL-2	Manufacturing (CMC)-New Strength		Label is not available on this site.
11/20/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040428

PROMETHAZINE HYDROCHLORIDE

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

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

Top