ALYQ
- Product NDC
- 0093-3334
- 11-digit product format
- 000933334
- Labeler code
- 0093
- Product ID
- 0093-3334_aff8cfda-2692-4975-af57-831a194d25d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA209942
- Marketing category
- ANDA
- Marketing start
- 2019-02-06
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0093-3334 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0093-3334 | 0093-3334-06 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209942-001 | ALYQ | TADALAFIL | 20MG | TABLET / ORAL | AB2 | | 2019-02-05 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A209942-001 | AB2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-3334-06 | 00093333406 | 60 TABLET, FILM COATED in 1 BOTTLE (0093-3334-06) | 2019-02-06 | 0000-00-00 | No | No | Current |