Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215636
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLENE BLUE | METHYLENE BLUE | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
METHYLENE BLUE | METHYLENE BLUE | 50MG/10ML (5MG/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 |
---|---|---|---|---|---|---|---|
12/05/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215636Orig1s000ltr.pdf |
METHYLENE BLUE
SOLUTION;INTRAVENOUS; 10MG/2ML (5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLENE BLUE | METHYLENE BLUE | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215636 | ZYDUS LIFESCIENCES |
PROVAYBLUE | METHYLENE BLUE | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204630 | PROVEPHARM SAS |
SOLUTION;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLENE BLUE | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215636 | ZYDUS LIFESCIENCES |
PROVAYBLUE | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 204630 | PROVEPHARM SAS |