Application 074980
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACYCLOVIR | ACYCLOVIR | TABLET;ORAL | 400MG | No | No |
| 002 | ACYCLOVIR | ACYCLOVIR | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-039 | Acyclovir | acyclovir | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-010 | Acyclovir | acyclovir | Rebel Distributors Corp | ANDA | Current |
| 21695-011 | Acyclovir | acyclovir | Rebel Distributors Corp | NDA AUTHORIZED GENERIC | Current |
| 63304-504 | Acyclovir | acyclovir | Ranbaxy Laboratories Ltd. | ANDA | Current |
| 63304-505 | Acyclovir | acyclovir | Ranbaxy Laboratories Ltd. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30727 | ORIG | 1998-09-30 |