Drugs@FDA: FDA-Approved Drugs
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | 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 |
---|---|---|---|---|---|---|---|
01/20/2011 | 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 |
---|---|---|---|---|---|
01/03/2020 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/03/2020 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/03/2020 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2020 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/03/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
04/08/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
05/24/2013 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/24/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2012 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/17/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/05/2014 | SUPPL-6 | Labeling |
Label is not available on this site. |
PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090797 | ACTAVIS TOTOWA |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205119 | AMNEAL PHARMS |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | ATLANTIDE |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202038 | AUROBINDO PHARMA LTD |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077619 | DR REDDYS LABS LTD |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202882 | HETERO LABS LTD V |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090901 | JUBILANT GENERICS |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203024 | L PERRIGO CO |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078281 | LANNETT CO INC |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090970 | MYLAN PHARMS INC |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202052 | ORCHID HLTHCARE |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090807 | RUBICON |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090074 | TORRENT PHARMS |
PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
TABLET, DELAYED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090797 | ACTAVIS TOTOWA |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205119 | AMNEAL PHARMS |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | ATLANTIDE |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202038 | AUROBINDO PHARMA LTD |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077619 | DR REDDYS LABS LTD |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202882 | HETERO LABS LTD V |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211368 | INGENUS PHARMS LLC |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090901 | JUBILANT GENERICS |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078281 | LANNETT CO INC |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090970 | MYLAN PHARMS INC |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202052 | ORCHID HLTHCARE |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090807 | RUBICON |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090074 | TORRENT PHARMS |
PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English