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Application 020843
- Type
- NDA
- Sponsor
- VIRTUS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROMETRIUM | PROGESTERONE | CAPSULE; ORAL | 100MG | No | No |
| 002 | PROMETRIUM | PROGESTERONE | CAPSULE; ORAL | 200MG | No | No |
| 003 | PROMETRIUM | PROGESTERONE | CAPSULE; ORAL | 300MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 35497 | SUPPL | 2011-11-04 |
| 26031 | SUPPL | 2011-11-03 |
| 3547 | SUPPL | 2009-07-07 |
| 35496 | SUPPL | 2009-07-06 |
| 41757 | ORIG | 2005-06-16 |
| 26029 | SUPPL | 2004-12-10 |
| 26028 | SUPPL | 2004-12-10 |
| 13589 | SUPPL | 2004-12-10 |
| 13588 | SUPPL | 2004-12-10 |
| 26030 | SUPPL | 2004-03-10 |
| 35495 | ORIG | 1998-12-16 |
| 26027 | ORIG | 1998-12-16 |