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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011265
Company: ANI PHARMS

Products on NDA 011265

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011265

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1957	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2009	SUPPL-31	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011265s031ltr.pdf
04/02/2008	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf
01/16/2004	SUPPL-28	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11265slr028ltr.pdf
02/23/2001	SUPPL-27	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/011265_S027_PHERGAN_AP.pdf
05/06/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
02/27/1996	SUPPL-24	Labeling		Label is not available on this site.
03/30/1992	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/16/1989	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1988	SUPPL-19	Efficacy-Rx To OTC Switch		Label is not available on this site.
09/16/1985	SUPPL-18	Labeling		Label is not available on this site.
07/31/1985	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/29/1986	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/1984	SUPPL-14	Labeling		Label is not available on this site.
04/02/1984	SUPPL-13	Efficacy		Label is not available on this site.
04/02/1984	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 011265

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2008	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf
04/02/2008	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf

Therapeutic Equivalents for NDA 011265

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

SYRUP;ORAL; 15MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE DM	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040649	SLATE RUN PHARMA
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	090575	AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	011265	ANI PHARMS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	091687	TRIS PHARMA INC
PROMETHAZINE W/ DEXTROMETHORPHAN	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	088864	WOCKHARDT BIO AG

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