Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008662
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYDRAZID | ISONIAZID | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 09/29/1952 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2025 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008662s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/008662Orig1s020ltr.pdf | |
| 06/19/2002 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-15 | Labeling |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/14/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/17/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/15/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/28/1976 | SUPPL-6 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/05/2025 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008662s020lbl.pdf |