Application 088191
- Type
- ANDA
- Sponsor
- WOCKHARDT BIO AG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LINDANE | LINDANE | SHAMPOO;TOPICAL | 1% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60432-834 | Lindane | lindane | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
| 60432-834 | Lindane | lindane | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
| 60432-834 | Lindane | lindane | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
| 60432-834 | Lindane | lindane | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44411 | ORIG | 2003-12-17 |