Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088017
Company: ACTAVIS MID ATLANTIC

Products on ANDA 088017

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088017

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/1983	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
06/28/2018	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-48	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2016	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
11/21/2014	SUPPL-45	Labeling		Label is not available on this site.
09/12/2000	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/22/1997	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/09/1997	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/02/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/02/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/19/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/07/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/01/1990	SUPPL-10	Labeling		Label is not available on this site.
07/31/1990	SUPPL-9	Labeling		Label is not available on this site.
06/08/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/11/1988	SUPPL-7	Labeling		Label is not available on this site.
02/13/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/09/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/09/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088017

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

SYRUP;ORAL; 1.5MG/5ML;5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	005213	GENUS
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	207487	ABHAI LLC
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	088017	ACTAVIS MID ATLANTIC
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	203535	NOVEL LABS INC
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	205731	PADAGIS US
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	088008	WOCKHARDT BIO AG