RAMELTEON tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)

Tersedia dari:

Zydus Lifesciences Limited

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] . Patients who develop angioedema after treatment with ramelteon should not be rechallenged with the drug. Patients should not take ramelteon in conjunction with fluvoxamine [see Drug Interactions (7)] . Risk Summary Available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than

Ringkasan produk:

Ramelteon tablets, 8 mg are available as light yellow to beige-coloured, round, biconvex bevel edged, film-coated tablets, debossed with "1344"on one side and plain on other side and are supplied as follows: NDC 70771-1495-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1495-1 in bottles of 100 tablets NDC 70771-1495-5 in bottles of 500 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: ccb643ba-3ba2-485e-9419-339d5c68dc1a
34391-3
Set id: 14ba7994-476a-4978-8cac-29989335a63c
Version: 4
Effective Time: 20230927
Zydus Lifesciences Limited

Karakteristik produk

RAMELTEON- RAMELTEON TABLET
ZYDUS LIFESCIENCES LIMITED
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RAMELTEON TABLETS
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1495-3
Ramelteon Tablets, 8 mg
30 Tablets
Rx only
RAMELTEON
ramelteon tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1495
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)
RAMELTEON
8 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (light yellow to beige coloured)
SCORE
no score
SHAPE
ROUND
SIZE
7mm
FLAVOR
IMPRINT CODE
1344
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1495-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
07/23/2019
2
NDC:70771-
1495-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
07/23/2019
3
NDC:70771-
1495-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
07/23/2019
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA211567
07/23/2019
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1495) , MANUFACTURE(70771-1495)
Zydus Lifesciences Limited
Revised: 9/2023