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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088017
Company: ACTAVIS MID ATLANTIC
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
07/05/1983 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-49 Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-48 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

11/21/2014 SUPPL-45 Labeling

Label is not available on this site.

09/12/2000 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/22/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/02/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/02/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/19/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/07/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/01/1990 SUPPL-10 Labeling

Label is not available on this site.

07/31/1990 SUPPL-9 Labeling

Label is not available on this site.

06/08/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/11/1988 SUPPL-7 Labeling

Label is not available on this site.

02/13/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/09/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/09/1986 SUPPL-3 Manufacturing (CMC)

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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