Details for New Drug Application (NDA): 205299
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The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 205299
Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205299
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 205299
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 205299 | ANDA | Dr.Reddys Laboratories Inc | 43598-579 | 43598-579-30 | 30 POUCH in 1 CARTON (43598-579-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-579-01) |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 205299 | ANDA | Dr.Reddys Laboratories Inc | 43598-582 | 43598-582-30 | 30 POUCH in 1 CARTON (43598-582-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-582-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE | ||||
Approval Date: | Jun 14, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
Approval Date: | Jun 14, 2018 | TE: | AB | RLD: | No |
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