Application 090609
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| 002 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 18MG | No | No |
| 003 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
| 004 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 40MG | No | No |
| 005 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 60MG | No | No |
| 006 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 80MG | No | No |
| 007 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6908 | Atomoxetine | Atomoxetine | Major Pharmaceuticals | ANDA | Current |
| 0904-6908 | Atomoxetine | Atomoxetine | Major Pharmaceuticals | ANDA | Current |
| 0904-6908 | Atomoxetine | Atomoxetine | Major Pharmaceuticals | ANDA | Current |
| 55111-519 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-519 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-519 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-519 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-520 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-520 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-520 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-520 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-521 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-521 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-521 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-521 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-522 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-522 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-522 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-522 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-528 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-528 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-528 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-528 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-563 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-563 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-563 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-563 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-564 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-564 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-564 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-564 | Atomoxetine | Atomoxetine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 63629-9427 | Atomoxetine | Atomoxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-9428 | Atomoxetine | Atomoxetine | Bryant Ranch Prepack | ANDA | Current |