Application 076112
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 400MG | No | No |
| 002 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 600MG | No | No |
| 003 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49999-042 | IBU | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-042 | IBU | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43052 | ORIG | 2001-10-31 |