Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208961
Company: ZYDUS PHARMS
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
12/27/2017 ORIG-1 Approval STANDARD

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 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 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 074958 TEVA
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 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 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 074958 TEVA
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 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 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 074958 TEVA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

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