An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213219
Company: MICRO LABS

Products on ANDA 213219

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213219

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	211822	ALEMBIC
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	216440	AUROBINDO PHARMA
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	074364	CHARTWELL RX
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	211364	IXORA LIFESCIENCE
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	213219	MICRO LABS
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	TP ANDA HOLDINGS
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	212285	UNIQUE
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	211822	ALEMBIC
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	216440	AUROBINDO PHARMA
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	074364	CHARTWELL RX
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	211364	IXORA LIFESCIENCE
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	213219	MICRO LABS
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	TP ANDA HOLDINGS
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	212285	UNIQUE
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	211822	ALEMBIC
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE;ORAL	Prescription	No	AB	216440	AUROBINDO PHARMA
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE;ORAL	Prescription	No	AB	074364	CHARTWELL RX
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE;ORAL	Prescription	No	AB	211364	IXORA LIFESCIENCE
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	213219	MICRO LABS
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	TP ANDA HOLDINGS
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE;ORAL	Prescription	No	AB	212285	UNIQUE
CLOMIPRAMINE HYDROCHLORIDE	CLOMIPRAMINE HYDROCHLORIDE	75MG	CAPSULE;ORAL	Prescription	No	AB	208961	ZYDUS PHARMS

Top