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 | Discontinued | None | Yes | No |
| IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TOFRANIL | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | Yes | No |
| 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 |