Application 203511
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 450MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-765 | Valganciclovir | Valganciclovir | NorthStar Rx LLC | ANDA | Current |
| 16714-765 | Valganciclovir | Valganciclovir | NorthStar Rx LLC | ANDA | Current |
| 16714-765 | Valganciclovir | Valganciclovir | NorthStar Rx LLC | ANDA | Current |
| 16714-765 | Valganciclovir | Valganciclovir | NorthStar Rx LLC | ANDA | Current |
| 48433-124 | Valganciclovir | Valganciclovir | Safecor Health, LLC | ANDA | Current |
| 48433-124 | Valganciclovir | Valganciclovir | Safecor Health, LLC | ANDA | Current |
| 48433-124 | Valganciclovir | Valganciclovir | Safecor Health, LLC | ANDA | Current |
| 55111-762 | Valganciclovir | Valganciclovir | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-762 | Valganciclovir | Valganciclovir | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-762 | Valganciclovir | Valganciclovir | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 60429-846 | Valganciclovir | Valganciclovir | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-846 | Valganciclovir | Valganciclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-846 | Valganciclovir | Valganciclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-846 | Valganciclovir | Valganciclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 68084-965 | Valganciclovir | Valganciclovir | American Health Packaging | ANDA | Current |
| 68084-965 | Valganciclovir | Valganciclovir | American Health Packaging | ANDA | Current |
| 68084-965 | Valganciclovir | Valganciclovir | American Health Packaging | ANDA | Current |
| 68084-965 | Valganciclovir | Valganciclovir | American Health Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32436 | ORIG | 2014-11-10 |