Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074364
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 03/29/1996 | 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 |
|---|---|---|---|---|---|
| 06/02/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2020 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 06/02/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/18/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/14/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/29/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/29/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/14/2005 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/19/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/09/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/22/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/10/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/31/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/25/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/10/1997 | 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 |