Drug Name and FDA Application Number | Dosage Form/Route | Strength | Marketing Status | Company |
OMEPRAZOLE
(NDA # 022032)
| TABLET, DELAYED RELEASE; ORAL |
20MG
|
Tentative Approval
| DEXCEL LTD |
OMEPRAZOLE
(ANDA # 075268)
| Capsule; Oral |
10MG 20MG
|
Tentative Approval
| GENPHARM |
OMEPRAZOLE
(ANDA # 075347)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG 40MG
|
Tentative Approval
| ANDRX PHARMS |
OMEPRAZOLE
(ANDA # 075410)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG
|
Prescription
| KREMERS URBAN DEV |
OMEPRAZOLE
(ANDA # 075576)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG 10MG
|
Prescription
| DR REDDYS LABS LTD |
OMEPRAZOLE
(ANDA # 075576)
| CAPSULE, DELAYED RELEASE; ORAL |
10MG 20MG 10MG
|
Tentative Approval
| DR REDDYS LABS LTD |
OMEPRAZOLE
(ANDA # 075757)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG
|
Prescription
| LEK PHARMS |
OMEPRAZOLE
(ANDA # 075785)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG 40MG
|
Prescription
| IMPAX LABS |
OMEPRAZOLE
(ANDA # 075791)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG
|
Tentative Approval
| SANDOZ |
OMEPRAZOLE
(ANDA # 075876)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG 40MG
|
Prescription
| MYLAN |
OMEPRAZOLE
(ANDA # 076048)
| CAPSULE, DELAYED REL PELLETS; ORAL |
10MG 20MG 40MG
|
Prescription
| APOTEX |
OMEPRAZOLE
(ANDA # 076048)
| Capsule, Delayed-Release |
10MG 20MG 40MG
|
Tentative Approval
| APOTEX |
OMEPRAZOLE
(ANDA # 076515)
| CAPSULE, DELAYED RELEASE; ORAL |
40MG
|
Tentative Approval
| LEK PHARM |