Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204068
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription AB No No
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;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
07/15/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204068Orig1s000ltr.pdf

OMEPRAZOLE AND SODIUM BICARBONATE

CAPSULE;ORAL; 20MG;1.1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 204228 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 204922 AUROLIFE PHARMA LLC
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 204068 DR REDDYS LABS LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 078966 PAR PHARM
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 207476 SCIEGEN PHARMS INC
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription No AB 203290 ZYDUS PHARMS
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Prescription Yes AB 021849 SALIX

CAPSULE;ORAL; 40MG;1.1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 204228 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 204922 AUROLIFE PHARMA LLC
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 204068 DR REDDYS LABS LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 078966 PAR PHARM
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 207476 SCIEGEN PHARMS INC
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription No AB 203290 ZYDUS PHARMS
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Prescription Yes AB 021849 SALIX

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