Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020756
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CRINONE | PROGESTERONE | 8% | GEL;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/13/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020756_crinone_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/17/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr012ltr.pdf |
| 04/20/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S10ltr.pdf |
| 04/03/2001 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S9ltr.pdf |
| 12/16/1998 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/11/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/11/1997 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |