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 |
| 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 |