Skip to contentApplication 209844
- Type
- NDA
- Sponsor
- CHARTWELL PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LYMEPAK | DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 100MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-596 | LymePak | Doxycycline Hyclate | Chartwell RX, LLC. | NDA | Current |
| 62135-596 | LymePak | Doxycycline Hyclate | Chartwell RX, LLC. | NDA | Current |
| 62135-596 | LymePak | Doxycycline Hyclate | Chartwell RX, LLC. | NDA | Current |
| 72336-596 | LymePak | Doxycycline Hyclate | LIFSA DRUGS LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81863 | SUPPL | 2025-04-08 |
| 81799 | SUPPL | 2025-04-02 |
| 57544 | SUPPL | 2019-02-13 |
| 57347 | SUPPL | 2019-01-25 |
| 56421 | ORIG | 2018-11-13 |
| 54671 | ORIG | 2018-06-21 |
| 54634 | ORIG | 2018-06-21 |