Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216120
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 0.4MG/ML (0.4MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/26/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216120Orig1s000ltr.pdf |
ATROPINE SULFATE
SOLUTION;INTRAVENOUS; 0.4MG/ML (0.4MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 0.4MG/ML (0.4MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 214652 | ACCORD HLTHCARE |
ATROPINE SULFATE | ATROPINE SULFATE | 0.4MG/ML (0.4MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216120 | AM REGENT |
SOLUTION;INTRAVENOUS; 1MG/ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 214652 | ACCORD HLTHCARE |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216120 | AM REGENT |