Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018651
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MARINOL | DRONABINOL | 2.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MARINOL | DRONABINOL | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| MARINOL | DRONABINOL | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf | |
| 08/28/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf | |
| 06/21/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf | |
| 06/21/2006 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf | |
| 04/26/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf | |
| 04/28/2003 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf | |
| 09/22/2000 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/018651s013lbl.pdf |