Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018261
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PITOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| PITOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| PITOCIN | OXYTOCIN | 500USP UNITS/50ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1980 | 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 |
|---|---|---|---|---|---|
| 05/11/2021 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018261Orig1s041ltr.pdf | |
| 08/15/2016 | SUPPL-33 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/18/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018261Orig1s031ltr.pdf | |
| 07/27/2007 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018261s028ltr.pdf | |
| 03/24/2003 | SUPPL-23 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18261slr023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018261_s023_PITOCIN_LBL.pdf |
| 09/24/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-21 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18261s21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018261_s021_PITOCIN_LBL.pdf |
| 03/08/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/08/2001 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/08/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/10/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18261-s011_pitocin.pdf |
| 02/22/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/27/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/09/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/16/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/29/1987 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/11/2021 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf | |
| 05/11/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf | |
| 10/02/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf | |
| 07/27/2007 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf | |
| 07/27/2007 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf |
PITOCIN
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 | ENDO OPERATIONS |
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 | ENDO OPERATIONS |