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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040613
Company: PAI HOLDINGS PHARM

Products on ANDA 040613

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/2008	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-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040613

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	040613	PAI HOLDINGS PHARM
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP;ORAL	Prescription	No	AA	088008	WOCKHARDT BIO AG

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