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USFDA APPLICATION NUMBER - 21324 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 3MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| BUDESONIDE(UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) | BUDESONIDE | 3mg |
Inactive Ingredients
| Ingredient Name | Teva Pharmaceuticals USA, Inc. | Alvogen, Inc. | American Health Packaging | APPCO PHARMA LLC | AstraZeneca Pharmaceuticals LP | Golden State Medical Supply, Inc. | Lake Erie Medical DBA Quality Care Products LLC | Mayne Pharma Inc. | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | Padagis US LLC | Paddock Laboratories, LLC | Par Pharmaceutical Inc. | Zydus Pharmaceuticals USA Inc. | Amneal Pharmaceuticals LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACETIC ACID(Q40Q9N063P) | |||||||||||||||
| Acetyltributyl citrate(0ZBX0N59RZ) | |||||||||||||||
| ALCOHOL(3K9958V90M) | |||||||||||||||
| Ammonia(5138Q19F1X) | |||||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||||
| CETYL ALCOHOL(936JST6JCN) | |||||||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | |||||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | |||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||
| DIMETHICONE(92RU3N3Y1O) | |||||||||||||||
| Ethyl Acrylate(71E6178C9T) | |||||||||||||||
| Ethylcellulose (10 MPA.S)(3DYK7UYZ62) | |||||||||||||||
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | |||||||||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | |||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||||
| Hypromellose, Unspecified(3NXW29V3WO) | |||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | |||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | |||||||||||||||
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J) | |||||||||||||||
| METHACRYLIC ACID(1CS02G8656) | |||||||||||||||
| METHYL ALCOHOL(Y4S76JWI15) | |||||||||||||||
| Polyethylene Glycol, Unspecified(3WJQ0SDW1A) | |||||||||||||||
| POLYSORBATE 80(6OZP39ZG8H) | |||||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | |||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||
| SUCROSE(C151H8M554) | |||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||||||
| TRIETHYL CITRATE(8Z96QXD6UM) | |||||||||||||||
| WATER(059QF0KO0R) |
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