Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088811
Company: WOCKHARDT BIO AG

Products on ANDA 088811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMFED-DM	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/1985	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
06/03/2016	SUPPL-26	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/03/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/03/2016	SUPPL-18	Labeling-Container/Carton Labels		Label is not available on this site.
09/30/2004	SUPPL-13	Labeling		Label is not available on this site.
01/12/1999	SUPPL-10	Labeling		Label is not available on this site.
03/04/1994	SUPPL-9	Labeling		Label is not available on this site.
08/19/1991	SUPPL-8	Labeling		Label is not available on this site.
05/10/1989	SUPPL-6	Labeling		Label is not available on this site.
04/05/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/17/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/15/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/15/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/08/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088811

BROMFED-DM

SYRUP;ORAL; 2MG/5ML;10MG/5ML;30MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BROMFED-DM	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	088811	WOCKHARDT BIO AG
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	203375	ACELLA
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	210647	ALKEM LABS LTD
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	213125	CHARTWELL MOLECULAR
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	207676	DR REDDYS LABS SA
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	205292	PADAGIS US
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	202940	PHARM ASSOC
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	205112	TARO
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	2MG/5ML;10MG/5ML;30MG/5ML	SYRUP;ORAL	Prescription	No	AA	211170	WES PHARMA INC