Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212435
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/03/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212435Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/17/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/17/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/17/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
METRONIDAZOLE IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 500MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLAGYL I.V. RTU IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018657 | BAXTER HLTHCARE |
METRO I.V. IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018900 | B BRAUN |
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 217665 | AMNEAL |
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 078084 | BAXTER HLTHCARE CORP |
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212435 | GLAND PHARMA LTD |
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018890 | HOSPIRA |
METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206191 | INFORLIFE |