Orange Book product · Brand (NDA)
LOMOTIL
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Strength
0.025MG;2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
NDA 012462
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —LOMOTILBrand (NDA)
NDA 012699 · GD SEARLE LLC
- 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
- 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.
