Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
At a glance
Jun 11, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength
1.5MG/5ML;5MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 210663
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- 1988HYCODANBrand (NDA)
NDA 005213 · GENUS
- 2017HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEGeneric (ANDA)
ANDA 207176 · AVANTHI INC
- 2017HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 204765 · SCIEGEN PHARMS
- 2017HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 207487 · ABHAI LLC
- 2017HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 205731 · PADAGIS US
- 2017HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 203535 · NOVEL LABS INC
- 2011HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEGeneric (ANDA)
ANDA 091528 · NOVEL LABS INC
- 2008HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 040613 · GENUS LIFESCIENCES
- 2000HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEGeneric (ANDA)
ANDA 040295 · ACTAVIS ELIZABETH
- 1999HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 040285 · IVAX SUB TEVA PHARMS
- 1985TUSSIGONGeneric (ANDA)
ANDA 088508 · KING PHARMS
- 1985HYDROPANEGeneric (ANDA)
ANDA 088066 · HALSEY
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
