Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212868
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATROPINE SULFATE | ATROPINE SULFATE | 0.25MG/5ML (0.05MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| ATROPINE SULFATE | ATROPINE SULFATE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| ATROPINE SULFATE | ATROPINE SULFATE | 1MG/10ML (0.1MG/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 |
|---|---|---|---|---|---|---|---|
| 07/26/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212868Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/07/2023 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/23/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ATROPINE SULFATE
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; 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; 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 |