Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018248
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| OXYTOCIN | OXYTOCIN | 300USP UNITS/30ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/09/1980 | 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 |
|---|---|---|---|---|---|
| 09/20/2022 | SUPPL-49 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018248s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018248Orig1s049ltr.pdf | |
| 09/10/2014 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2007 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018248s034_ltr.pdf |
| 10/11/2000 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/31/2000 | SUPPL-27 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf |
| 02/22/1999 | SUPPL-26 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf |
| 07/02/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/13/1995 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/20/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/14/1985 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1984 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1983 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/12/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/10/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2022 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018248s049lbl.pdf | |
| 09/20/2022 | SUPPL-49 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018248s049lbl.pdf |
OXYTOCIN
INJECTABLE;INJECTION; 10USP UNITS/ML (10USP UNITS/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018248 | FRESENIUS KABI USA |
| OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018243 | HIKMA |
| OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200219 | HIKMA FARMACEUTICA |
| OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091676 | SAGENT PHARMS INC |
| PITOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018261 | PAR STERILE PRODUCTS |
INJECTABLE;INJECTION; 100USP UNITS/10ML (10USP UNITS/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018248 | FRESENIUS KABI USA |
| OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018243 | HIKMA |
| OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091676 | SAGENT PHARMS INC |
| PITOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018261 | PAR STERILE PRODUCTS |