Application 075523
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE;EQ 50MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-506 | pentazocine and naloxone | pentazocine and naloxone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76097 | ORIG | 2023-11-02 |
| 53968 | ORIG | 2018-05-01 |
| 30923 | ORIG | 2000-03-17 |
| 22481 | ORIG | 2000-03-17 |