Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075141
Company: GALT PHARMS
Company: GALT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORPHENGESIC | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 385MG;30MG;25MG | TABLET;ORAL | Prescription | None | No | No |
| ORPHENGESIC FORTE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 770MG;60MG;50MG | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/29/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75141ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |