Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207176
Company: AVANTHI INC

Products on ANDA 207176

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207176

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2017	ORIG-1	Approval		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
07/05/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207176

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

TABLET;ORAL; 1.5MG;5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET;ORAL	Prescription	No	AA	207176	AVANTHI INC
HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET;ORAL	Prescription	Yes	AA	005213	GENUS