Application 076335
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRI-PREVIFEM | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0603-7663 | Tri-Previfem | norgestimate and ethinyl estradiol | Par Pharmaceutical | ANDA | Current |
| 0603-7663 | Tri-Previfem | norgestimate and ethinyl estradiol | Par Pharmaceutical | ANDA | Current |
| 53002-1304 | Tri-Previfem | norgestimate and ethinyl estradiol | RPK Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22554 | ORIG | 2007-07-06 |