ZOLMITRIPTAN tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)

থেকে পাওয়া:

Zydus Lifesciences Limited

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use - Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. - Zolmitriptan tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of zolmitriptan have not been established for cluster - headache. Zolmitriptan tablets are contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1) ] - Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see

পণ্য সারাংশ:

Zolmitriptan Tablets USP, 2.5 mg are light yellow to yellow colored, round-shaped, biconvex, film-coated tablets with breakline on one side and debossed with "7" on other side and are supplied as follows:   NDC 65841-765-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets   Zolmitriptan Tablets USP, 5 mg are light orange to orange colored, round-shaped, biconvex beveled edge, film-coated tablets debossed with '714' on one side and plain on other side and are supplied as follows:   NDC 65841-766-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets   Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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ZOLMITRIPTAN TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-765-86 in unit-dose blister cartons of 6 (1 x 6) unit dose
tablets
Zolmitriptan Tablets, 2.5 mg
Rx only
100 tablets
ZYDUS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-766-82 in unit-dose blister cartons of 3 (1 x 3) unit dose
tablets
Zolmitriptan Tablets, 5 mg
Rx only
100 tablets
ZYDUS
ZOLMITRIPTAN
zolmitriptan tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-765
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)
Z OLMITRIPTAN
2.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (LIGHT YELLOW to YELLOW)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
7
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-765-
86
1 in 1 CARTON
11/12/2018
1
6 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA203019
11/12/2018
ZOLMITRIPTAN
zolmitriptan tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-766
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZOLMITRIPTAN (UNII: