Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088636
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1984 | 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 |
|---|---|---|---|---|---|
| 11/13/2019 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/13/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/05/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/10/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089069 | HOSPIRA |
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 088636 | INTL MEDICATION |
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206332 | NEXUS |