Details for New Drug Application (NDA): 020076
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NDA 020076 describes HABITROL, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from twelve suppliers. Additional details are available on the HABITROL profile page.
The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020076
| Tradename: | HABITROL |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | nicotine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020076
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076 | NDA | Walgreens Company | 0363-0451 | 0363-0451-74 | 14 PATCH in 1 CARTON (0363-0451-74) / 24 h in 1 PATCH |
| HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076 | NDA | Walgreens Company | 0363-0455 | 0363-0455-70 | 7 PATCH in 1 CARTON (0363-0455-70) / 24 h in 1 PATCH |
Profile for product number 004
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7MG/24HR | ||||
| Approval Date: | Nov 12, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 14MG/24HR | ||||
| Approval Date: | Nov 12, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 21MG/24HR | ||||
| Approval Date: | Nov 12, 1999 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020076
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-004 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-004 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-006 | Nov 12, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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