FDA.reportPublic FDA data

Application 208077

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1210Diclofenac sodiumDiclofenac sodiumWalgreensANDACurrent
0363-1210Diclofenac sodiumDiclofenac sodiumWalgreensANDACurrent
0536-1294Diclofenac sodiumDiclofenac sodiumRugby Laboratories, Inc.ANDACurrent
0536-1294Diclofenac sodiumDiclofenac sodiumRugby Laboratories, Inc.ANDACurrent
0536-1294Diclofenac sodiumDiclofenac sodiumRugby Laboratories, Inc.ANDACurrent
0536-1294Diclofenac sodiumDiclofenac sodiumRugby Laboratories, Inc.ANDACurrent
0536-1294Diclofenac sodiumDiclofenac sodiumRugby Laboratories, Inc.ANDACurrent
11822-7300Arthritis Pain RelieverDiclofenac sodiumRite Aid CorporationANDACurrent
11822-7300Arthritis Pain RelieverDiclofenac sodiumRite Aid CorporationANDACurrent
11822-8120Arthritis Pain RelieverDiclofenac sodiumRite Aid CorporationANDACurrent
11822-8120Arthritis Pain RelieverDiclofenac sodiumRite Aid CorporationANDACurrent
11822-8120Arthritis Pain RelieverDiclofenac sodiumRite Aid CorporationANDACurrent
17856-0833Diclofenac sodiumDiclofenacATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0833Diclofenac sodiumDiclofenacATLANTIC BIOLOGICALS CORP.ANDACurrent
21130-028Diclofenac sodiumDiclofenac sodiumSafeway, Inc.ANDACurrent
41250-973Diclofenac sodiumDiclofenac sodiumMEIJER, INC.ANDACurrent
41250-973Diclofenac sodiumDiclofenac sodiumMEIJER, INC.ANDACurrent
42291-256Diclofenac sodiumDiclofenacAvKARE, Inc.ANDACurrent
42291-256Diclofenac sodiumDiclofenacAvKARE, Inc.ANDACurrent
42291-256Diclofenac sodiumDiclofenacAvKAREANDACurrent
49035-269Diclofenac sodiumDiclofenac sodiumEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-269Diclofenac sodiumDiclofenac sodiumEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
50090-2787Diclofenac sodiumDiclofenacA-S Medication SolutionsANDACurrent
50090-2787Diclofenac sodiumDiclofenacA-S Medication SolutionsANDACurrent
50090-4621Diclofenac sodiumDiclofenacA-S Medication SolutionsANDACurrent
50268-237Diclofenac sodiumDiclofenacAvPAKANDACurrent
50436-0833Diclofenac sodiumDiclofenacUnit Dose ServicesANDACurrent
51316-012Arthritis Pain RelieverDiclofenac sodiumCVS PHARMACY, INCANDACurrent
51316-073Arthritis Pain RelieverDiclofenac sodiumCVS PHARMACY, INCANDACurrent
55328-801SalonpasDiclofenac SodiumHisamitsu America, Inc.ANDACurrent
55328-801SalonpasDiclofenac SodiumHisamitsu America, Inc.ANDACurrent
55700-675Diclofenac sodiumDiclofenacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-675Diclofenac sodiumDiclofenacLake Erie Medical DBA Quality Care Products LLCANDACurrent
59088-709VennGel Onediclofenac sodium, isopropyl alcoholPureTek CorporationANDACurrent
59088-709VennGel Onediclofenac sodium, isopropyl alcoholPureTek CorporationANDACurrent
59088-709VennGel Onediclofenac sodium, isopropyl alcoholPureTek CorporationANDACurrent
59088-709VennGel Onediclofenac sodium, isopropyl alcoholPureTek CorporationANDACurrent
59088-709VennGel Onediclofenac sodium, isopropyl alcoholPureTek CorporationANDACurrent
59726-012Arthritis Pain RelieverDiclofenac sodiumP & L Development, LLCANDACurrent
59726-012Arthritis Pain RelieverDiclofenac sodiumP & L Development, LLCANDACurrent
59726-012Arthritis Pain RelieverDiclofenac sodiumP & L Development, LLCANDACurrent
63187-762Diclofenac sodiumDiclofenacProficient Rx LPANDACurrent
63187-762Diclofenac sodiumDiclofenacProficient Rx LPANDACurrent
63941-812Diclofenac sodiumDiclofenac sodiumBest Choice (Valu Merchandisers Company)ANDACurrent
63941-812Diclofenac sodiumDiclofenac sodiumBest Choice (Valu Merchandisers Company)ANDACurrent
63941-812Diclofenac sodiumDiclofenac sodiumBest Choice (Valu Merchandisers Company)ANDACurrent
63981-112Diclofenac sodiumDiclofenac sodiumCostco WholesaleANDACurrent
63981-112Diclofenac sodiumDiclofenac sodiumCostco WholesaleANDACurrent
63981-112Diclofenac sodiumDiclofenac sodiumCostco WholesaleANDACurrent
65162-833Diclofenac sodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-833Diclofenac sodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-833Diclofenac sodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-833Diclofenac sodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
68016-171Arthritis Pain RelieverDiclofenac sodiumChain Drug Consortium, LLCANDACurrent
68016-171Arthritis Pain RelieverDiclofenac sodiumChain Drug Consortium, LLCANDACurrent
68016-171Arthritis Pain RelieverDiclofenac sodiumChain Drug Consortium, LLCANDACurrent
68071-3159Diclofenac sodiumDiclofenacNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4246Diclofenac sodiumDiclofenacNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6831Diclofenac sodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-6831Diclofenac sodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
69238-2053Diclofenac sodiumDiclofenacAmneal Pharmaceuticals NY LLCANDACurrent
69238-2053Diclofenac sodiumDiclofenacAmneal Pharmaceuticals NY LLCANDACurrent
69238-2053Diclofenac sodiumDiclofenacAmneal Pharmaceuticals NY LLCANDACurrent
69256-012Arthritis Pain RelieverDiclofenac sodiumHarris Teeter, LLCANDACurrent
69256-012Arthritis Pain RelieverDiclofenac sodiumHarris Teeter, LLCANDACurrent
69256-012Arthritis Pain RelieverDiclofenac sodiumHarris Teeter, LLCANDACurrent
69336-827DICLOZORDICLOFENAC SODIUMSterling-Knight Pharmaceuticals, LLCANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
69842-974Diclofenac sodiumDiclofenac sodiumCVS PharmacyANDACurrent
70000-0555Diclofenac sodiumDiclofenac sodiumCardinal Health (Leader) 70000ANDACurrent
70000-0555Diclofenac sodiumDiclofenac sodiumCardinal Health (Leader) 70000ANDACurrent
70000-0555Diclofenac sodiumDiclofenac sodiumCardinal Health (Leader) 70000ANDACurrent
70518-1333Diclofenac sodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-1333Diclofenac sodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-1333Diclofenac sodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-1333Diclofenac sodiumDiclofenacREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57653ORIG2019-02-15