Is there a generic for Lindane?

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Lindane, referencing the brand KWELL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lindane?

KWELL (NDA 006309, REED AND CARNRICK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lindane are approved?

Lindane is approved in the following dosage forms: cream, lotion, shampoo.

FDA Orange Book · active-ingredient family

Lindane

Lindane: 2 brands, 10 generics; first approved Apr 08, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 10 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

KWELL

REED AND CARNRICKNDA 006309—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	—
1%	LOTION	TOPICAL	Discontinued	—

KWELL

REED AND CARNRICKNDA 010718—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (10)

LINDANE

WOCKHARDT BIO AGANDA 0881911984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

LINDANE

WOCKHARDT BIO AGANDA 0881901984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	—

SCABENE

STIEFELANDA 0879401983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

KWELL

REED AND CARNRICKANDA 084218—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	—
1%	LOTION	TOPICAL	Discontinued	—

GAMENE

SOLA BARNES HINDANDA 084989—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	—

LINDANE

OLTA PHARMSANDA 087313—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	—

SCABENE

STIEFELANDA 086769—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	—

GAMENE

SOLA BARNES HINDANDA 084988—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

KWELL

REED AND CARNRICKANDA 084219—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

LINDANE

OLTA PHARMSANDA 087266—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Apr 08, 1983

43 yr 11 mo ago

Most recent approval

Sep 18, 1984

42 yr 5 mo ago

Approvals span 1983–1984 across 12 FDA applications.

Brand (NDA) 217%

Generic (ANDA) 1083%

Lindane — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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