Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088864
Company: WOCKHARDT BIO AG

Products on ANDA 088864

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/1985	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
06/07/2006	SUPPL-27	Labeling		Label is not available on this site.
07/09/1997	SUPPL-23	Labeling		Label is not available on this site.
07/09/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/09/1997	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/09/1997	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/09/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/09/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
10/18/1991	SUPPL-16	Labeling		Label is not available on this site.
08/24/1990	SUPPL-15	Labeling		Label is not available on this site.
06/19/1989	SUPPL-14	Labeling		Label is not available on this site.
04/05/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/16/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/26/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/06/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088864

PROMETHAZINE W/ DEXTROMETHORPHAN

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	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