Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
At a glance
Mar 03, 1983
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 03, 1983
43 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength
1.5MG/5ML;5MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 088008
Product number
001
Marketing status
RX
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
- 2019HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGeneric (ANDA)
ANDA 210663 · SANKALP LIFECARE
- 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
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.
