Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074953
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription AB No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/02/2020 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/02/2020 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

11/20/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription Yes AB 019906 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 211364 LEADING PHARMA LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 211767 MANKIND PHARMA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 213219 MICRO LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 210653 TULEX PHARMS INC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 212285 UNIQUE PHARM LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 213221 VGYAAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription Yes AB 019906 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 211364 LEADING PHARMA LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 211767 MANKIND PHARMA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 213219 MICRO LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 210653 TULEX PHARMS INC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 212285 UNIQUE PHARM LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 213221 VGYAAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

CAPSULE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription Yes AB 019906 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 211364 LEADING PHARMA LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 211767 MANKIND PHARMA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 213219 MICRO LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 210653 TULEX PHARMS INC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 212285 UNIQUE PHARM LABS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 213221 VGYAAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English