Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078830
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/30/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078830Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078830Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/078830Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2023 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078830Orig1s000lbl.pdf |
SCOPOLAMINE
SYSTEM;TRANSDERMAL; 1MG/72HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 208769 | ACTAVIS LABS UT INC |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 203753 | MYLAN TECHNOLOGIES |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 078830 | PADAGIS US |
| SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 212342 | RICONPHARMA LLC |
| TRANSDERM SCOP | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 017874 | BAXTER HLTHCARE CORP |