Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074416
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | AN | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1994 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-7 | Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 01/03/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/07/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
ISOFLURANE
LIQUID;INHALATION; 99.9%
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FORANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | Yes | AN | 017624 | BAXTER HLTHCARE |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 075225 | HALOCARBON PRODS |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 074416 | PIRAMAL CRITICAL |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 074502 | PIRAMAL PHARMA |