Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018245
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNTOCINON | OXYTOCIN | 10USP UNITS/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1980 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 04/29/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/13/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 06/08/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1986 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/04/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/07/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1981 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1980 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/09/1980 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |