Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011120
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | 75MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/1957 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2001 | SUPPL-86 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11120S86ltr.pdf |
| 03/27/2000 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1998 | SUPPL-81 | Labeling |
Label is not available on this site. |