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USFDA APPLICATION NUMBER - 21438 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) | PROPRANOLOL HYDROCHLORIDE | 120mg | 80mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Avera McKennan Hospital | Lake Erie Medical DBA Quality Care Products LLC | REMEDYREPACK INC. | Akrimax Pharmaceuticals, LLC | Mylan Pharmaceuticals Inc. | Rouses Point Pharm | Upsher-Smith Laboratories, Inc. | American Health Packaging | Bryant Ranch Prepack | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Golden State Medical Supply, Inc. | Unit Dose Services | Mist Pharmaceuticals, LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ammonia(5138Q19F1X) | ||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | ||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||||
| DIBUTYL SEBACATE(4W5IH7FLNY) | ||||||||||||||
| diethyl phthalate(UF064M00AF) | ||||||||||||||
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH) | ||||||||||||||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | ||||||||||||||
| ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV) | ||||||||||||||
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||||||||
| ferric oxide red(1K09F3G675) | ||||||||||||||
| ferric oxide yellow(EX438O2MRT) | ||||||||||||||
| ferrosoferric oxide(XM0M87F357) | ||||||||||||||
| GELATIN(2G86QN327L) | ||||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||||||
| HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | ||||||||||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||||||||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||||||||
| hypromellose phthalate (24% phthalate, 55 CST)(87Y6436BKR) | ||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||
| polyethylene glycol 400(B697894SGQ) | ||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||||||||||
| potassium hydroxide(WZH3C48M4T) | ||||||||||||||
| povidone K29/32(390RMW2PEQ) | ||||||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||||||
| POWDERED CELLULOSE(SMD1X3XO9M) | ||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||||||
| SHELLAC(46N107B71O) | ||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||||
| SUCROSE(C151H8M554) | ||||||||||||||
| TALC(7SEV7J4R1U) | ||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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