Application 091023
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 002 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 75MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-671 | Clopidogrel bisulfate | Clopidogrel bisulfate | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-671 | Clopidogrel bisulfate | Clopidogrel bisulfate | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-671 | Clopidogrel bisulfate | Clopidogrel bisulfate | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-671 | Clopidogrel bisulfate | Clopidogrel bisulfate | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-671 | Clopidogrel bisulfate | Clopidogrel bisulfate | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 63739-178 | Clopidogrel bisulfate | Clopidogrel bisulfate | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-178 | Clopidogrel bisulfate | Clopidogrel bisulfate | McKesson Corporation dba SKY Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31511 | ORIG | 2012-05-18 |