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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005213
Company: GENUS

Medication Guide

Products on NDA 005213

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005213

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/1943	ORIG-1	Approval	Type 1 - New Molecular Entity	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
12/15/2023	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005213s046lbl.pdf
09/27/2021	SUPPL-44		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213Orig1s044lbl.pdf
06/28/2018	SUPPL-39	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005213Orig1s039ltr.pdf
01/13/2017	SUPPL-38	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005213Orig1s038ltr.pdf
01/26/2009	SUPPL-37	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005213s037ltr.pdf
01/16/2002	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/2001	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/23/1999	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
07/10/2000	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/22/1992	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1988	SUPPL-23	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005213Orig1s023.pdf
12/23/1988	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/1988	SUPPL-15	Labeling		Label is not available on this site.
07/26/1988	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/1988	SUPPL-13	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 005213

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005213s046lbl.pdf
09/27/2021	SUPPL-44	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213Orig1s044lbl.pdf
06/28/2018	SUPPL-39	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf
06/28/2018	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf
01/13/2017	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf
01/13/2017	SUPPL-38	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf
01/26/2009	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf

Therapeutic Equivalents for NDA 005213

HYCODAN

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

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

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