Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)
Zydus Lifesciences Limited
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
Zydus Lifesciences Limited ---------- 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 Pročitajte cijeli dokument
RAMELTEON- RAMELTEON TABLET ZYDUS LIFESCIENCES LIMITED ---------- 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 Pročitajte cijeli dokument