LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Jai Pharma Limited

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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