Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203306
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
01/13/2016 | 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 |
---|---|---|---|---|---|
07/21/2020 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2020 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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 | 207157 | LANNETT CO INC |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 203187 | MYLAN |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 203306 | NATCO PHARMA LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 202319 | PERRIGO R AND D |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | No | 202727 | WOCKHARDT LTD |
PREVACID 24 HR | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Over-the-counter | Yes | 022327 | PERRIGO PHARMA INTL |
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