FDA.report

Application 075576

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-2302OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2305OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
16714-714OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-714OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-714OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-714OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-714OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-715OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-715OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-715OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-715OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
16714-715OmeprazoleOmeprazoleNorthStar Rx LLCANDACurrent
21695-617OmeprazoleOmeprazoleRebel Distributors CorpANDACurrent
33261-087OmeprazoleOmeprazoleAidarex Pharmaceuticals LLCANDACurrent
33261-117OmeprazoleOmeprazoleAidarex Pharmaceuticals LLCANDACurrent
33261-441OmeprazoleOmeprazoleAidarex Pharmaceuticals LLCANDACurrent
42254-043OmeprazoleOmeprazoleRebel Distributors CorpANDACurrent
42254-053OmeprazoleOmeprazoleRebel Distributors CorpANDACurrent
43063-549OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-549OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-549OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-549OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-549OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-743OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-342OmeprazoleOmeprazoleMedsource PharmaceuticalsANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
49999-265OmeprazoleOmeprazoleQuality Care Products, LLCANDACurrent
50090-1157OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-1157OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-1157OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-4829OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-4829OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50436-3126OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-8158OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
51655-061OmeprazoleOmeprazoleNorthwind PharmaceuticalsANDACurrent
51655-061OmeprazoleOmeprazoleNorthwind PharmaceuticalsANDACurrent
53002-1104OmeprazoleOmeprazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-1104OmeprazoleOmeprazoleRPK Pharmaceuticals, Inc.ANDACurrent
53808-1052OmeprazoleOmeprazoleState of Florida DOH Central PharmacyANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-157OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-158OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55111-159OmeprazoleOmeprazoleDr. Reddy's Laboratories LimitedANDACurrent
55154-6648OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-6648OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-6648OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-6648OmeprazoleOmeprazoleCardinal HealthANDACurrent