Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207891
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | 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 |
---|---|---|---|---|---|---|---|
10/12/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207891Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/12/2023 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/16/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
OMEPRAZOLE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, DELAYED RELEASE;ORAL; 20MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 210070 | APOTEX |
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 022032 | DEXCEL PHARMA |
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 207740 | DR REDDYS |
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 207891 | SUN PHARM |