Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088212
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 05/26/1983 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/06/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/12/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/04/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/20/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CYPROHEPTADINE HYDROCHLORIDE
TABLET;ORAL; 4MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 206553 | APPCO |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 206676 | BEXIMCO PHARMS USA |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 088212 | CHARTWELL RX |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 040644 | KENTON |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 040537 | MOUNTAIN |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 205087 | NOVAST LABS |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 212491 | QUAGEN |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 207555 | RISING |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 209172 | STRIDES PHARMA |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 208938 | ZYDUS PHARMS |