clindamycin phosphate · Pfizer · NDA 050537, 050680, 050767

Cleocin

Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • Generic approved · ANDA 218300, Rising · 050537-002Approved 23 Mar 2026Detected 25 Oct 2026Historical import

Products covered · 4

NDA · productFormStrengthListed expiry
050537 · 002 · RLD · discontinuedswab, topicalEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
050680 · 001 · discontinuedcream, vaginalEQ 2% BASEopen
050680 · 002 · RLDcream, vaginalEQ 2% BASEopen
050767 · 001 · RLDsuppository, vaginal100MGopen