Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212342
Company: RICONPHARMA LLC
Company: RICONPHARMA LLC
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 |
---|---|---|---|---|---|---|---|
11/24/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
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 | 215329 | RHODES PHARMS |
SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 212342 | RICONPHARMA LLC |
SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 217893 | ZYDUS PHARMS |
TRANSDERM SCOP | SCOPOLAMINE | 1MG/72HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 017874 | BAXTER HLTHCARE CORP |