Orange Book product · Generic (ANDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
At a glance
May 03, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 03, 1982
44 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Strength
0.025MG/5ML;2.5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 087708
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- —LOMOTILBrand (NDA)
NDA 012699 · GD SEARLE LLC
- —LOMOTILBrand (NDA)
NDA 012462 · PFIZER
- 2021DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 211362 · WINDER LABS LLC
- 2020DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 207128 · CHARTWELL RX
- 2020DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 213335 · SPECGX LLC
- 2020DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 210789 · DR REDDYS LABS SA
- 2020DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 213413 · LEADING
- 2018DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 210819 · UNICHEM
- 2018DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 210571 · QUAGEN
- 2000DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 040395 · ABLE
- 2000DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 040357 · STRIDES PHARMA INTL
- 1985LOGENGeneric (ANDA)
ANDA 088962 · SUPERPHARM
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.
