Application 206586
- Type
- ANDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.3MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-179 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-179 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-179 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10582 | ORIG | 2015-07-30 |