Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074694
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
12/31/1996 | 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 |
---|---|---|---|---|---|
11/30/2015 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/20/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/29/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/20/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/14/1999 | 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 | 213897 | AJANTA PHARMA LTD |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211822 | ALEMBIC |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 208632 | AMNEAL PHARMS CO |
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 | CHEMISTRY HLTH |
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 | TULEX PHARMS INC |
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 | 213897 | AJANTA PHARMA LTD |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211822 | ALEMBIC |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 208632 | AMNEAL PHARMS CO |
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 | CHEMISTRY HLTH |
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 | TULEX PHARMS INC |
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 | 213897 | AJANTA PHARMA LTD |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 211822 | ALEMBIC |
CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 208632 | AMNEAL PHARMS CO |
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 | CHEMISTRY HLTH |
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 | TULEX PHARMS INC |
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 |