Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200602
Company: BAYSHORE PHARMS LLC
Company: BAYSHORE PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 2.5MG | TABLET;ORAL | Prescription | AA | No | No |
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 5MG | TABLET;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/24/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
METHSCOPOLAMINE BROMIDE
TABLET;ORAL; 2.5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AA | 216786 | AACE PHARMS |
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AA | 200602 | BAYSHORE PHARMS LLC |
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AA | 040642 | BRECKENRIDGE PHARM |
TABLET;ORAL; 5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 216786 | AACE PHARMS |
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 200602 | BAYSHORE PHARMS LLC |
METHSCOPOLAMINE BROMIDE | METHSCOPOLAMINE BROMIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 040642 | BRECKENRIDGE PHARM |