Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007409
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/11/2013 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf | |
| 08/01/2011 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf | |
| 02/02/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |