Application 208299
- Type
- ANDA
- Sponsor
- PRINSTON PHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43547-005 | ROFLUMILAST | roflumilast | Solco Healthcare US, LLC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55329 | ORIG | 2018-08-27 |