Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217638
Company: WANBANG BIOPHARMS
Company: WANBANG BIOPHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | 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 |
---|---|---|---|---|---|---|---|
06/12/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GUANFACINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200881 | ACTAVIS ELIZABETH |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217269 | ALEMBIC |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205689 | SUN PHARM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201382 | TEVA PHARMS USA |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201408 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217638 | WANBANG BIOPHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200881 | ACTAVIS ELIZABETH |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217269 | ALEMBIC |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205689 | SUN PHARM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201382 | TEVA PHARMS USA |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201408 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217638 | WANBANG BIOPHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
TABLET, EXTENDED RELEASE;ORAL; EQ 3MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200881 | ACTAVIS ELIZABETH |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217269 | ALEMBIC |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205689 | SUN PHARM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201382 | TEVA PHARMS USA |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201408 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217638 | WANBANG BIOPHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200881 | ACTAVIS ELIZABETH |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217269 | ALEMBIC |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205689 | SUN PHARM |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201382 | TEVA PHARMS USA |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201408 | TWI PHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217638 | WANBANG BIOPHARMS |
GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |