Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087846
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TOFRANIL | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/22/1984 | 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 |
|---|---|---|---|---|---|
| 06/29/2017 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf | |
| 09/27/2007 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026pi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/087844Orig1s025,087845Orig1s025,087846Orig1s026ltr.pdf | |
| 06/25/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/12/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/31/2004 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/14/2000 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/14/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/20/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/14/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf | |
| 09/27/2007 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026pi.pdf |
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040903 | LEADING |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040751 | OXFORD PHARMS |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 084936 | SANDOZ |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 087846 | SPECGX LLC |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 088292 | STRIDES PHARMA |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 081048 | SUN PHARM INDUSTRIES |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040903 | LEADING |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040751 | OXFORD PHARMS |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 083745 | SANDOZ |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 087846 | SPECGX LLC |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 088262 | STRIDES PHARMA |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 081049 | SUN PHARM INDUSTRIES |
TOFRANIL
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040903 | LEADING |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040751 | OXFORD PHARMS |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 084937 | SANDOZ |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 088276 | STRIDES PHARMA |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 081050 | SUN PHARM INDUSTRIES |
| TOFRANIL | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 087846 | SPECGX LLC |