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USFDA APPLICATION NUMBER - 22370 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) | TRAMADOL HYDROCHLORIDE | 300mg | 200mg | 100mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Lake Erie Medical DBA Quality Care Products LLC | SA3, LLC | STA3, LLC | Unit Dose Services | Vertical Pharmaceuticals Inc. | Vertical Pharmaceuticals, LLC | Bryant Ranch Prepack | Preferred Pharmaceuticals Inc. | Proficient Rx LP |
|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||
| D&C RED NO. 7(ECW0LZ41X8) | ||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
| ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI) | ||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
| GELATIN(2G86QN327L) | ||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||||||||
| POVIDONE K29/32(390RMW2PEQ) | ||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||
| SHELLAC(46N107B71O) | ||||||||||
| SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D) | ||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||
| SUCROSE STEARATE(274KW0O50M) | ||||||||||
| TALC(7SEV7J4R1U) | ||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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