Application 076588
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 500MG BASE | No | No |
| 002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 1GM BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43063-200 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 51407-107 | Valacyclovir | Valacyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-108 | Valacyclovir | Valacyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 51660-904 | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE | Ohm Laboratories Inc. | ANDA | Current |
| 51660-905 | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE | Ohm Laboratories Inc. | ANDA | Current |
| 63304-904 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 63304-904 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 63304-904 | Valacyclovir | Valacyclovir | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-904 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 63304-905 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 63304-905 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 63304-905 | Valacyclovir | Valacyclovir | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-905 | Valacyclovir | Valacyclovir | SUN PHARMACEUTICAL INDUSTRIES, INC. | ANDA | Current |
| 68071-3276 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0323 | Valacyclovir | Valacyclovir | REMEDYREPACK INC. | ANDA | Current |