Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009402
Company: PAR STERILE PRODUCTS
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DELESTROGEN | ESTRADIOL VALERATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | Yes |
| DELESTROGEN | ESTRADIOL VALERATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AO | Yes | Yes |
| DELESTROGEN | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AO | 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 |
|---|---|---|---|---|---|---|---|
| 07/15/1954 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009402s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/009402Orig1s063ltr.pdf | |
| 02/16/2022 | SUPPL-60 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/009402Orig1s060ltr.pdf | |
| 11/01/2017 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009402s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009402Orig1s052ltr.pdf | |
| 03/10/2016 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/2015 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2015 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2007 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009402s041ltr.pdf |
| 07/26/2004 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09402s040ltr.pdf | |
| 12/12/2003 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf | |
| 07/17/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2003 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf | |
| 06/17/1998 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 01/12/1990 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 12/28/1987 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/11/1987 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/05/1986 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1985 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/16/1984 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 06/01/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/18/1983 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1982 | SUPPL-19 | 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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009402s063lbl.pdf | |
| 02/16/2022 | SUPPL-60 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf | |
| 02/16/2022 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf | |
| 11/01/2017 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009402s052lbl.pdf | |
| 07/26/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf | |
| 12/12/2003 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf | |
| 12/12/2003 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf |
DELESTROGEN
INJECTABLE;INJECTION; 10MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DELESTROGEN | ESTRADIOL VALERATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 009402 | PAR STERILE PRODUCTS |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 203723 | HIKMA |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 216656 | XIROMED |
INJECTABLE;INJECTION; 40MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DELESTROGEN | ESTRADIOL VALERATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 009402 | PAR STERILE PRODUCTS |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 090920 | AM REGENT |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 203723 | HIKMA |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 216656 | XIROMED |
INJECTABLE;INJECTION; 20MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DELESTROGEN | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 009402 | PAR STERILE PRODUCTS |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 090920 | AM REGENT |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 203723 | HIKMA |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 216656 | XIROMED |