Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214652
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
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 | Yes | Yes |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | 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 |
---|---|---|---|---|---|---|---|
09/29/2020 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214652Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214652Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/29/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.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 |
ATROPINE SULFATE | ATROPINE SULFATE | 0.4MG/ML (0.4MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215969 | SOMERSET THERAPS LLC |
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 |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215969 | SOMERSET THERAPS LLC |