اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت MYLAN TECHNOLOGIES
Abbreviated New Drug Application (ANDA): 207607
Company: MYLAN TECHNOLOGIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription |
AB |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/14/2018 | ORIG-2 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s001ltr_2.pdf |
|
| 06/14/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s000Ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2018 | SUPPL-1 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
FILM;BUCCAL, SUBLINGUAL; EQ 8MG BASE;EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN PINE BROOK |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205299 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR INC |
FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN PINE BROOK |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205806 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR INC |
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