Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)
Cadila Healthcare Limited
ORAL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ERLOTINIB- ERLOTINIB TABLET, FILM COATED CADILA HEALTHCARE LIMITED ---------- ERLOTINIB TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Erlotinib Tablets, 25 mg 30 tablets NDC 70771-1521-3 Rx only Erlotinib Tablets, 100 mg 30 tablets NDC 70771-1522-3 Rx only Erlotinib Tablets, 150 mg 30 tablets NDC 70771-1523-3 Rx only ERLOTINIB erlotinib tablet, film coated PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:70 771-1521 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ERLO TINIB HYDRO CHLO RIDE (UNII: DA8 770 5X9 K) (ERLOTINIB - UNII:J4T8 2NDH7E) ERLOTINIB 25 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CRO SPO VIDO NE ( 12 0 .MU.M) (UNII: 6 8 40 19 6 0 MK) HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 ) LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) MICRO CRYSTALLINE CELLULO SE 10 1 (UNII: 7T9 FYH5QMK) MICRO CRYSTALLINE CELLULO SE 10 2 (UNII: PNR0 YF6 9 3Y) PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) PRODUCT CHARACTERISTICS COLOR WHITE (Off-white) S CORE no sco re S HAP E ROUND (Ro und) S IZ E 6 mm FLAVOR IMPRINT CODE 9 13 CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70 771-1521-3 30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/30 /20 20 2 NDC:70 771-1521-9 9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/30 /20 20 3 NDC:70 771-1521-7 3 in 1 CARTON 0 4/30 /20 20 3 NDC:70 771-1521-2 10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE ANDA ANDA2130 6 5 0 4/30 /20 20 ERLOTINIB erlotinib tablet, film coated PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:70 771-1522 ROUTE OF ADMINISTRATION Przeczytaj cały dokument