Application 009402
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | DELESTROGEN | ESTRADIOL VALERATE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
| 003 | DELESTROGEN | ESTRADIOL VALERATE | INJECTABLE;INJECTION | 40MG/ML | Yes | Yes |
| 004 | DELESTROGEN | ESTRADIOL VALERATE | INJECTABLE;INJECTION | 20MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-110 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-110 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-111 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-111 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-112 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-112 | Delestrogen | estradiol valerate | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77565 | SUPPL | 2024-02-20 |
| 77542 | SUPPL | 2024-02-16 |
| 70232 | SUPPL | 2022-02-23 |
| 70180 | SUPPL | 2022-02-17 |
| 50306 | SUPPL | 2017-11-06 |
| 50267 | SUPPL | 2017-11-02 |
| 191 | SUPPL | 2007-10-15 |
| 33002 | SUPPL | 2004-07-28 |
| 190 | SUPPL | 2004-07-28 |
| 10728 | SUPPL | 2004-06-02 |
| 33001 | SUPPL | 2003-12-16 |
| 189 | SUPPL | 2003-12-16 |
| 188 | SUPPL | 2003-12-16 |