Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021146
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
ATROPINE SULFATE | ATROPINE SULFATE | 0.25MG/5ML (0.05MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/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 |
---|---|---|---|---|---|---|---|
07/09/2001 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/30/2020 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021146Orig1s025ltr.pdf | |
06/24/2020 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021146Orig1s022ltr.pdf | |
11/01/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.pdf | |
08/17/2017 | SUPPL-18 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s018lbl.pdf | |
01/31/2017 | SUPPL-16 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021146Orig1s016ltr.pdf |
10/30/2015 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021146Orig1s015ltr.pdf | |
03/12/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/30/2020 | SUPPL-25 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s025lbl.pdf | |
06/24/2020 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf | |
06/24/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021146Orig1s022lbl.pdf | |
11/01/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s019lbl.pdf | |
08/17/2017 | SUPPL-18 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021146s018lbl.pdf |
10/30/2015 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021146s015lbl.pdf | |
07/09/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-146_Atropine%20Sulfate_prntlbl.pdf |
ATROPINE SULFATE
SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212868 | ACCORD HLTHCARE |
ATROPINE SULFATE | ATROPINE SULFATE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215342 | AMNEAL |
ATROPINE SULFATE | ATROPINE SULFATE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021146 | HOSPIRA |
SOLUTION;INTRAVENOUS; 0.25MG/5ML (0.05MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 0.25MG/5ML (0.05MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212868 | ACCORD HLTHCARE |
ATROPINE SULFATE | ATROPINE SULFATE | 0.25MG/5ML (0.05MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021146 | HOSPIRA |
SOLUTION;INTRAVENOUS; 1MG/10ML (0.1MG/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/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212868 | ACCORD HLTHCARE |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215342 | AMNEAL |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021146 | HOSPIRA |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212461 | INTL MEDICATION SYS |
ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214970 | MEDEFIL INC |