Application 018261
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PITOCIN | OXYTOCIN | INJECTABLE;INJECTION | 10USP UNITS/ML (10USP UNITS/ML) | Yes | Yes |
| 002 | PITOCIN | OXYTOCIN | INJECTABLE;INJECTION | 100USP UNITS/10ML (10USP UNITS/ML) | Yes | No |
| 003 | PITOCIN | OXYTOCIN | INJECTABLE;INJECTION | 500USP UNITS/50ML (10USP UNITS/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-116 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-116 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-116 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-116 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-130 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-130 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-130 | Pitocin | oxytocin | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68286 | SUPPL | 2021-08-04 |
| 67460 | SUPPL | 2021-05-12 |
| 33465 | SUPPL | 2014-10-03 |
| 883 | SUPPL | 2014-10-03 |
| 40790 | SUPPL | 2008-04-04 |
| 20120 | SUPPL | 2008-04-04 |
| 14961 | SUPPL | 2007-07-31 |
| 33464 | SUPPL | 2007-07-30 |
| 14960 | SUPPL | 2003-03-26 |
| 14959 | SUPPL | 2002-01-10 |
| 40789 | SUPPL | 1997-07-29 |