Application 211785
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | No | No |
| 002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 4MG BASE;EQ 1MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-8765 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8765 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8765 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8766 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8766 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8766 | Buprenorphine and Naloxone | Buprenorphine and Naloxone | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76394 | ORIG | 2023-11-06 |