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 PHARMA |
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 |