Application 076390
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-250 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Dr.Reddys Laboratories Limited | ANDA | Current |
| 55111-250 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Dr.Reddys Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31116 | ORIG | 2007-07-05 |