Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214442
Company: AIPING PHARM INC
Company: AIPING PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | AB | No | No |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| CAPTOPRIL | CAPTOPRIL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CAPTOPRIL
TABLET;ORAL; 12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 214442 | AIPING PHARM INC |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074677 | ANDAS 5 HOLDING |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074737 | COREPHARMA |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT BIO AG |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 214442 | AIPING PHARM INC |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074677 | ANDAS 5 HOLDING |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074737 | COREPHARMA |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT BIO AG |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 214442 | AIPING PHARM INC |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074677 | ANDAS 5 HOLDING |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074737 | COREPHARMA |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT BIO AG |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 214442 | AIPING PHARM INC |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074677 | ANDAS 5 HOLDING |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074737 | COREPHARMA |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT BIO AG |