Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019185
Company: ABBOTT
Company: ABBOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | OXYTOCIN | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/29/1985 | 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 |
---|---|---|---|---|---|
11/13/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
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07/01/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |