Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Jai Pharma Limited
LEVONORGESTREL
LEVONORGESTREL 0.1 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL ESTRADIOL JAI PHARMA LIMITED ---------- LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, (0.1 MG/0.02 MG) AND ETHINYL ESTRADIOL TABLETS USP, (0.01 MG) PACKAGE LABEL.PRINCIPAL DISPLAY PANEL LEVONORGESTREL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol kit PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:579 9 4-0 0 8 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:579 9 4-0 0 8 -9 0 2 in 1 CARTON 0 1/0 1/20 17 1 1 in 1 POUCH 1 1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 8 4 PA RT 2 7 PART 1 OF 2 LEVONORGESTREL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol tablet PRODUCT INFORMATION ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH LEVO NO RGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 0 .1 mg ETHINYL ESTRADIO L (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0 .0 2 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) PO LACRILIN PO TASSIUM (UNII: 0 BZ5A0 0 FQU) PRODUCT CHARACTERISTICS COLOR WHITE S CORE no sco re S HAP E ROUND S IZ E 6 mm FLAVOR IMPRINT CODE 214 CONTAINS MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE ANDA ANDA20 0 49 3 0 1/0 1/20 17 PART 2 OF 2 ETHINYL ESTRADIOL ethinyl estradiol tablet PRODUCT INFORMATION ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ETHINYL ESTRADIO L (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0 .0 1 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH .ALPHA.-TO CO PHERO L, DL- (UNII: 7QWA1RIO0 1) ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK) CELLULO SE, MICRO CRYSTALLINE Les hele dokumentet