FDA — authorised 3 June 1977
- Application: ANDA085506
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Enlon-Plus in United States
FDA authorised Enlon-Plus on 3 June 1977
Marketing authorisations
FDA — authorised 5 July 1977
- Application: ANDA085035
- Marketing authorisation holder: R AND S PHARMA
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1978
- Application: ANDA085659
- Marketing authorisation holder: KV PHARM
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 1978
- Application: ANDA085509
- Marketing authorisation holder: INWOOD LABS
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 1978
- Application: ANDA085876
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 1978
- Application: NDA017744
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: MOTOFEN HALF-STRENGTH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1979
- Application: ANDA086727
- Marketing authorisation holder: ANI PHARMS
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 1981
- Application: ANDA086440
- Marketing authorisation holder: SCHERER RP
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 1981
- Application: ANDA087131
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1983
- Application: ANDA088009
- Marketing authorisation holder: VANGARD
- Local brand name: LO-TROL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1985
- Application: ANDA088962
- Marketing authorisation holder: SUPERPHARM
- Local brand name: LOGEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1990
- Application: NDA020056
- Marketing authorisation holder: US ARMY
- Local brand name: ATROPINE SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 5 March 1997
- Application: ANDA087195
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2000
- Application: ANDA040357
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2001
- Application: NDA021146
- Marketing authorisation holder: HOSPIRA
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 July 2014
- Application: NDA206289
- Marketing authorisation holder: RISING
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 June 2020
- Application: ANDA210789
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2020
- Application: ANDA212461
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 21 October 2020
- Application: ANDA207128
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2021
- Application: ANDA211362
- Marketing authorisation holder: WINDER LABS LLC
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2021
- Application: ANDA212868
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 November 2021
- Application: ANDA215624
- Marketing authorisation holder: APOTEX
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 December 2021
- Application: ANDA213561
- Marketing authorisation holder: HIKMA
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA215342
- Marketing authorisation holder: AMNEAL
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 March 2022
- Application: NDA213581
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA216120
- Marketing authorisation holder: AM REGENT
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 January 2024
- Application: ANDA218148
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA217791
- Marketing authorisation holder: SOMERSET
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 July 2024
- Application: ANDA215618
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 July 2024
- Application: ANDA215969
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 24 October 2025
- Application: ANDA217345
- Marketing authorisation holder: HIKMA
- Local brand name: ATROPINE SULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA087934
- Marketing authorisation holder: ASCOT
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA085121
- Marketing authorisation holder: WYETH AYERST
- Local brand name: MEPERIDINE AND ATROPINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085211
- Marketing authorisation holder: HALSEY
- Local brand name: LOW-QUEL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087853
- Marketing authorisation holder: ABBVIE
- Local brand name: ATROPINE AND DEMEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA086057
- Marketing authorisation holder: ROXANE
- Local brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
Enlon-Plus in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Enlon-Plus approved in United States?
Yes. FDA authorised it on 3 June 1977; FDA authorised it on 5 July 1977; FDA authorised it on 27 January 1978.
Who is the marketing authorisation holder for Enlon-Plus in United States?
SUN PHARM INDUSTRIES holds the US marketing authorisation.