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 از شرکت ALVOGEN
Abbreviated New Drug Application (ANDA): 211594
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription |
AB |
No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/2021 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211594Orig1s000TA_ltr.pdf |
BUPRENORPHINE HYDROCHLORIDE
FILM;BUCCAL; EQ 0.075MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.075MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.15MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.15MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.45MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.45MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.6MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.75MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
FILM;BUCCAL; EQ 0.9MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription | Yes | AB | 207932 | BDSI |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 0.9MG BASE | FILM;BUCCAL | Prescription | No | AB | 211594 | ALVOGEN |
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