Orange Book product · Generic (ANDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
At a glance
Jan 27, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2021
5 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Strength
0.025MG;2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 211362
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- —LOMOTILBrand (NDA)
NDA 012699 · GD SEARLE LLC
- —LOMOTILBrand (NDA)
NDA 012462 · PFIZER
- 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
- 1983DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEGeneric (ANDA)
ANDA 087934 · ASCOT
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.
