Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005213
Company: GENUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG/5ML;5MG/5ML SYRUP;ORAL Prescription AA Yes No
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

HYCODAN

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 040613 HI TECH PHARMA
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 PADDOCK LLC
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG/5ML;5MG/5ML SYRUP;ORAL Prescription No AA 204765 TORRENT
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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