Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203995
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
11/25/2016 | ORIG-1 | Approval |
Label is not available on this site. |
DICLOFENAC SODIUM AND MISOPROSTOL
TABLET, DELAYED RELEASE;ORAL; 50MG;0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020607 | PFIZER |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 201089 | ACTAVIS LABS FL INC |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203995 | AMNEAL PHARMS |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204355 | MICRO LABS |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200158 | SANDOZ |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205143 | YUNG SHIN PHARM |
TABLET, DELAYED RELEASE;ORAL; 75MG;0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020607 | PFIZER |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 201089 | ACTAVIS LABS FL INC |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203995 | AMNEAL PHARMS |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204355 | MICRO LABS |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200158 | SANDOZ |
DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205143 | YUNG SHIN PHARM |