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Application 087313
- Type
- ANDA
- Sponsor
- OLTA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LINDANE | LINDANE | LOTION;TOPICAL | 1% | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61748-401 | Lindane | Lindane | VersaPharm Incorporated | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 52761 | ORIG | 2018-02-28 |
| 44408 | ORIG | 2003-12-17 |