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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203535
Company: NOVEL LABS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/2017 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-2 Labeling-Package Insert

Label is not available on this site.

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 040613 AKORN
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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