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Application 075208
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55648-906 | RANITIDINE | RANITIDINE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-907 | RANITIDINE | RANITIDINE | WOCKHARDT LIMITED | ANDA | Current |
| 64679-906 | RANITIDINE | ranitidine | Wockhardt USA LLC. | ANDA | Current |
| 64679-906 | RANITIDINE | ranitidine | Wockhardt USA LLC. | ANDA | Current |
| 64679-907 | RANITIDINE | ranitidine | Wockhardt USA LLC. | ANDA | Current |
| 64679-907 | RANITIDINE | ranitidine | Wockhardt USA LLC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8564 | ORIG | 1998-12-17 |