Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202727
Company: GLENMARK PHARMS INC
Company: GLENMARK PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;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 |
---|---|---|---|---|---|---|---|
05/18/2012 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202727s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202727Orig1s000.pdf |
LANSOPRAZOLE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE, DELAYED REL PELLETS;ORAL; 15MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 202194 | DR REDDYS LABS LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 202727 | GLENMARK PHARMS INC |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 203306 | NATCO |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 202319 | PERRIGO R AND D |
PREVACID 24 HR | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | Yes | 022327 | PERRIGO PHARMA INTL |