Application 075742
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-735 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-735 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-735 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-736 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-736 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 55111-129 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-130 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8782 | ORIG | 2000-11-29 |