Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213590
Company: APPCO
Company: APPCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/31/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CHLORPROMAZINE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217350 | ALEMBIC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213590 | APPCO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213327 | LUPIN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215659 | TEVA PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 083386 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212630 | ZAMEER PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217350 | ALEMBIC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 213590 | APPCO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 213327 | LUPIN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 214827 | MSN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 215659 | TEVA PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 084112 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 212630 | ZAMEER PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 217350 | ALEMBIC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213590 | APPCO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213327 | LUPIN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 214827 | MSN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 215659 | TEVA PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 084113 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 212630 | ZAMEER PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 217350 | ALEMBIC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213590 | APPCO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213327 | LUPIN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214827 | MSN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 215659 | TEVA PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 084114 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212630 | ZAMEER PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 217350 | ALEMBIC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 213590 | APPCO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 213327 | LUPIN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 214827 | MSN |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 215659 | TEVA PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 084115 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 212630 | ZAMEER PHARMS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |