Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019906
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019906s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019906Orig1s043ltr.pdf | |
| 08/22/2018 | SUPPL-41 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019906Orig1s041Ltr.pdf |
| 05/24/2017 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019906Orig1s040ltr.pdf | |
| 07/28/2014 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf | |
| 07/10/2014 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf | |
| 10/26/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf | |
| 07/13/2007 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf | |
| 01/12/2005 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019906s032ltr.pdf | |
| 09/03/2004 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19906s030ltr.pdf |
| 06/20/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1999 | SUPPL-22 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019906_S022_ANAFRANIL_AP.pdf |
| 05/18/1998 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/02/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/11/1997 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/22/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/2001 | SUPPL-9 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf | |
| 04/13/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/09/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/31/1991 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/09/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019906s043lbl.pdf | |
| 05/24/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf | |
| 07/28/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf | |
| 07/10/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf | |
| 10/26/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf | |
| 07/13/2007 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf | |
| 01/12/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf | |
| 07/31/2001 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf |
ANAFRANIL
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 | 212218 | JUBILANT CADISTA |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211364 | LEADING |
| 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 | 213221 | RK PHARMA |
| 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 | 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 | 212218 | JUBILANT CADISTA |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211364 | LEADING |
| 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 | 213221 | RK PHARMA |
| 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 | 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 | 212218 | JUBILANT CADISTA |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 211364 | LEADING |
| 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 | 213221 | RK PHARMA |
| 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 | 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 |