USFDA APPLICATION NUMBER - 17377 / DOSAGE - TABLET;ORAL - 400MG;80MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
SULFAMETHOXAZOLE(UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV) | SULFAMETHOXAZOLE | 400mg | 800mg |
TRIMETHOPRIM(UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X) | TRIMETHOPRIM | 80mg | 160mg |
Inactive Ingredients
Ingredient Name | REMEDYREPACK INC. | Cardinal Health | A-S Medication Solutions | A-S Medication Solutions LLC | AR Scientific, Inc. | Aurobindo Pharma Limited | Bryant Ranch Prepack | Clinical Solutions Wholesale | Glenmark Generics Inc. USA | KAISER FOUNDATION HOSPITALS | LUCID PHARMA LLC | McKesson Corporation dba SKY Packaging | Mylan Institutional Inc. | Preferred Pharmaceuticals, Inc | Proficient Rx LP | Qualitest Pharmaceuticals | Sun Pharmaceutical Industries, Inc | Teva Pharmaceuticals USA, Inc. | American Health Packaging | Avera McKennan Hospital | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Golden State Medical Supply, Inc. | Lake Erie Medical DBA QualityL Care Products LC | Lake Erie Medical Quality Care Products LLC | McKesson Contract Packaging | NCS HealthCare of KY, Inc dba Vangard Labs | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals, Inc. | Unit Dose Services | REMEDYREPACK INC. |
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CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||||||||||||||
CROSPOVIDONE, UNSPECIFIED(2S7830E561) | |||||||||||||||||||||||||||||||
DOCUSATE SODIUM(F05Q2T2JA0) | |||||||||||||||||||||||||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||||||||||||||||||
FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||||||||||||||||||
FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||||||||||||||||||
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | |||||||||||||||||||||||||||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||||||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||||||||||||||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||||||||||||||||
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | |||||||||||||||||||||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||||||||||||||||
POVIDONE(FZ989GH94E) | |||||||||||||||||||||||||||||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||||||||||||||||||
POVIDONES(FZ989GH94E) | |||||||||||||||||||||||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||||||||||||||
SODIUM BENZOATE(OJ245FE5EU) | |||||||||||||||||||||||||||||||
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||||||||||||||||||||
STARCH, CORN(O8232NY3SJ) | |||||||||||||||||||||||||||||||
TALC(7SEV7J4R1U) | |||||||||||||||||||||||||||||||
TRIETHYL CITRATE(8Z96QXD6UM) |
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