Details for New Drug Application (NDA): 202446
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The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 202446
Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
Applicant: | Accord Hlthcare |
Ingredient: | amitriptyline hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 202446
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 202446 | ANDA | Major Pharmaceuticals | 0904-7184 | 0904-7184-61 | 100 BLISTER PACK in 1 CARTON (0904-7184-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 202446 | ANDA | Accord Healthcare Inc. | 16729-171 | 16729-171-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-171-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 4, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 4, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 4, 2014 | TE: | AB | RLD: | No |
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