Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074947
Company: MYLAN
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
04/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74947ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/29/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
03/18/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
10/16/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/09/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
05/03/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/31/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/11/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/03/2001 | SUPPL-1 | Labeling |
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 | 074947 | MYLAN |
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 | 074947 | MYLAN |
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 | 074947 | MYLAN |
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 |