Orange Book product · Generic (ANDA)
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
At a glance
Dec 01, 2000
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 01, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength
1.5MG;5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 040295
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
- 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
- 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.
