ERLOTINIB tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)

Sẵn có từ:

Cadila Healthcare Limited

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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