Application 202099
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZENATANE | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ZENATANE | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No |
| 003 | ZENATANE | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No |
| 004 | ZENATANE | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 72143-231 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-231 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-232 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-232 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-233 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-233 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-234 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-234 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-251 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-252 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-253 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
| 72143-254 | ACCUTANE | ISOTRETINOIN | JG Pharma Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44577 | ORIG | 2015-07-02 |